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: LRO
FDA class 2
General Surgery Tray
Adverse events in period
10,046
+159% vs. prior period (3,875)
Deaths reported
0
Recalls in period
160
Class I enforcement
78
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Injury
445
302
Malfunction
9,600
3,571
Other
1
1
Not specified
0
1
Most reported coded problems
Top 15Product problems
Count
Failure to Cut
5,215
Suction Problem
1,983
Suction Failure
704
Obstruction of Flow
405
Leak/Splash
353
Material Twisted/Bent
324
Break
324
Ambient Noise Problem
287
Infusion or Flow Problem
263
Air/Gas in Device
167
Incomplete or Inadequate Connection
153
Complete Blockage
149
Improper Flow or Infusion
134
Adverse Event Without Identified Device or Use Problem
118
Inability to Irrigate
110
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
7,342
Insufficient Information
2,319
Intraocular Pressure Decreased
100
Eye Burn
55
Eye Injury
44
Endophthalmitis
40
Toxic Anterior Segment Syndrome (TASS)
39
Retinal Tear
38
Capsular Bag Tear
35
Corneal Edema
34
Blurred Vision
29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
25
Retinal Detachment
23
Foreign Body In Patient
23
Inflammation
20
Recalls in period
160 total
FDA enforcement classification:
Class I: 78
Class II: 774
Date
Recalling firm
Status
Reason
2026-05-28
Open, Classified
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
2026-05-28
Open, Classified
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
2026-05-06
Open, Classified
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
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.
2026-04-30
Open, Classified
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
2026-04-27
Open, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-27
Open, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-27
Open, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-27
Open, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-04-27
Open, Classified
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
2026-04-10
Open, Classified
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
2026-04-02
Open, Classified
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
2026-03-24
Open, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-19
Open, Classified
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
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.
2026-03-17
Open, Classified
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
2026-03-16
Open, Classified
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
2026-03-16
Open, Classified
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
2026-03-13
Open, Classified
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
2026-02-27
Open, Classified
Unapproved design changes to the products outside of the 510(k) clearance.
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.
2026-02-27
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.
2026-02-27
Open, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
2026-02-27
Open, Classified
Unapproved design changes to the products outside of the 510(k) clearance.
2026-02-25
Open, Classified
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-18
Open, Classified
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
2026-02-16
Open, Classified
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
2026-01-08
Open, Classified
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
2026-01-08
Open, Classified
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
2026-01-08
Open, Classified
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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.
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.
2026-01-05
Open, Classified
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
2026-01-02
Open, Classified
Tyvek bag seal issue which may compromise sterility of the kit.
2025-12-24
Open, Classified
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
2025-12-16
Open, Classified
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
2025-12-12
Open, Classified
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
2025-11-26
Open, Classified
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
2025-11-24
Open, Classified
Ophthalmic procedure packs may have incomplete seals affecting sterility.
2025-10-10
Open, Classified
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
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.
2025-09-10
Open, Classified
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
2025-09-04
Open, Classified
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
2025-08-08
Open, Classified
Convenience kits labeled as sterile have not gone through the sterilization process.
2025-08-04
Open, Classified
Potential for open header bag seals, compromising sterility.
2025-08-04
Open, Classified
Potential for open header bag seals, compromising sterility.
2025-07-25
Open, Classified
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
2025-07-14
Open, Classified
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
2025-07-08
Open, Classified
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
2025-06-12
Open, Classified
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-06-11
Open, Classified
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
2025-05-23
Open, Classified
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
2025-05-15
Open, Classified
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
2025-04-28
Open, Classified
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
2025-04-22
Open, Classified
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
2025-03-31
Open, Classified
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
2025-03-19
Open, Classified
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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.
2025-02-24
Open, Classified
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
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.
2025-02-13
Open, Classified
Potential breach in pouch packaging which could lead to loss of sterility.
2025-02-13
Open, Classified
Potential breach in pouch packaging which could lead to loss of sterility.
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.
2025-02-10
Open, Classified
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06
Open, Classified
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-01-09
Open, Classified
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
2025-01-03
Open, Classified
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
2024-12-31
Open, Classified
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
2024-12-23
Open, Classified
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
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.
Showing the 100 most recent of 160 recalls — download the CSV for the full list shown here.
Adverse events by year
Loading...
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 LRO, 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 23:21 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.