Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 27, 2017 | Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical... | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspi... | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # ... | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical... | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Jun 27, 2017 | Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Us... | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Onl... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.