Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: KDD
FDA class 1
Kit, Surgical Instrument, Disposable
Adverse events in period
77
-13% vs. prior period (88)
Deaths reported
0
Recalls in period
179
Class I enforcement
39
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Injury
3
19
Malfunction
74
69
Most reported coded problems
Top 15Product problems
Count
Inadequate Lubrication
42
Therapeutic or Diagnostic Output Failure
6
Difficult to Open or Close
6
Break
5
No Apparent Adverse Event
4
Material Fragmentation
3
Improper or Incorrect Procedure or Method
3
Delivered as Unsterile Product
3
Defective Device
3
Contamination
3
Use of Device Problem
2
Unsealed Device Packaging
1
Physical Resistance/Sticking
1
Microbial Contamination of Device
1
Material Puncture/Hole
1
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
59
Failure of Implant
10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
10
Insufficient Information
6
Hemorrhage/Blood Loss/Bleeding
6
Foreign Body In Patient
3
Recalls in period
179 total
FDA enforcement classification:
Class I: 39
Class II: 463
Date
Recalling firm
Status
Reason
2026-05-04
Open, Classified
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
2026-04-21
Open, Classified
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
2026-03-19
Open, Classified
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
2026-03-11
Open, Classified
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
2026-03-11
Open, Classified
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
2026-03-11
Open, Classified
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
2026-02-27
Open, Classified
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.
Products not initially reported in RES 98601.
2026-01-07
Open, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
2026-01-07
Open, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
2025-12-16
Open, Classified
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
2025-12-16
Open, Classified
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
2025-09-30
Open, Classified
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
2025-03-03
Open, Classified
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2025-02-21
Open, Classified
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
2025-02-11
Open, Classified
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
2024-11-21
Open, Classified
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
2024-10-21
Open, Classified
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
2024-10-09
Open, Classified
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
2024-10-03
Open, Classified
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
2024-09-04
Open, Classified
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
2024-07-26
Open, Classified
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes
manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
Showing the 100 most recent of 179 recalls — download the CSV for the full list shown here.
Adverse events by year
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Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code KDD, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-05 23:49 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.