Browse Device Recalls
8 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 8 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 8 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2022 | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT | |
| Jun 6, 2022 | Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B,... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
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.