Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 3821–3840 of 38,428 recalls
Recalled Item: SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel BactiDrop Acridine Orange
The Issue: A color change of the solution within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and
The Issue: Identified higher-than-expected levels of endotoxin within the raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.