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: MLS FDA class 2

Labor And Delivery Kit

View full classification →

Adverse events in period

+7% vs. prior period (15)

Deaths reported

Recalls in period

Class I enforcement

Adverse events per month

2024-07 – 2026-06

🔒 Download CSV Pro

Events by type

Period vs. prior period

Event type

Period

Prior

Injury

Malfunction

🔒 Download CSV Pro

Most reported coded problems

Top 15

Product problems

Count

Material Split, Cut or Torn

Defective Device

Appropriate Device Problem Term/Code Not Available

Material Twisted/Bent

Inflation Problem

Decrease in Suction

Patient problems

Count

No Clinical Signs, Symptoms or Conditions

Insufficient Information

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

🔒 Download CSV Pro

Recalls in period

22 total

FDA enforcement classification: Class I: 20 Class II: 408

Date

Recalling firm

Status

Reason

2026-05-04

/fda_recalls/Z-2501-2026

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.

2026-04-27

/fda_recalls/Z-2429-2026

Open, Classified

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

2026-02-27

/fda_recalls/Z-1727-2026

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.

2026-02-25

/fda_recalls/Z-1845-2026

Open, Classified

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

2026-01-07

/fda_recalls/Z-2108-2026

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

/fda_recalls/Z-1414-2026

Open, Classified

2025-09-30

/fda_recalls/Z-0523-2026

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.

2025-09-04

American Contract Systems Inc.

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.

2025-07-14

American Contract Systems Inc

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.

2025-03-03

MEDLINE INDUSTRIES, LP Northfield

Open, Classified

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

2025-02-11

MEDLINE INDUSTRIES, LP Northfield

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.

2025-02-06

American Contract Systems Inc

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

American Contract Systems Inc

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

American Contract Systems Inc

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

American Contract Systems Inc

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.

2024-12-26

ROi CPS LLC

Open, Classified

There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

2024-11-21

MEDLINE INDUSTRIES, LP Northfield

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.

2024-10-16

MEDLINE INDUSTRIES, LP Northfield

Open, Classified

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

2024-10-09

MEDLINE INDUSTRIES, LP Northfield

Open, Classified

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

2024-09-04

MEDLINE INDUSTRIES, LP Northfield

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.

2024-08-07

American Contract Systems, Inc.

Open, Classified

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

2024-08-07

American Contract Systems, Inc.

Open, Classified

🔒 Download CSV Pro

Adverse events by year

🔒 Download CSV Pro

Methodology & data provenance

For your PSUR appendix

Search protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code MLS, 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 2026-03. 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: 2026-07-06 15:01 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.

🔒 Download summary CSV Pro

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.