AQUACEL AG FOAM 420647Recalls & reported problems

Convatec, Purchasing Department · AQUACEL FOAM AG ADH HEEL(1X5) NAI · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Convatec Aquacel Foam Ag Adhesive Heel dressing is a sterile foam wound dressing for heels. All 31 reports describe the same issue: wound care staff found a brownish discoloration on the sides of the dressings after peeling back the clear plastic cover and before applying them, and none of the dressings were used. There are no deaths and no injuries reported, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 31
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00768455123803), received between May 31, 2023 and May 31, 2023 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (31 reports).

1 other recall cover devices cleared under the same FDA submission (K123481); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Contamination /Decontamination Problem31
Delivered as Unsterile Product31

Patient problems

No Clinical Signs, Symptoms or Conditions31

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029498 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029497 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029496 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029495 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029494 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029493 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029492 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029491 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029490 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029487 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029486 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029485 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029464 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029463 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029462 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029461 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029460 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029459 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029458 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029457 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029438 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029436 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029435 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029434 ↗
MalfunctionMay 31, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR RECEIVED A PRODUCT COMPLAINT ABOUT COMPANY'S KNOWN THIRTY DRESSINGS FROM A HOSPITAL, WHERE THE WOUND CARE TEAM NOTICED A BROWNISH DISCOLORATION ON THE SIDES OF SOME PATCHES OF DRESSINGS AFTER REMOVING THE OUTER PLASTIC TRANSPARENT PART AND PRIOR TO APPLICATION. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123481. One submission often covers many models, so check the product and lot details in each record.

Z-0723-2023 · Nov 15, 2022 · Open, Classified
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Device details

UDI-DI	`00768455123803`
Brand	AQUACEL AG FOAM
Model	420647
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K123481
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Nov 8, 2022

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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