Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Oct 30, 2025 | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Mod... | Potential that the ligation loop was unable to release or detach as expected during use, causing ... | Class I | Olympus Corporation of the Americas |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Oct 29, 2025 | Outlook set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | B.BRAUN utilized in gravity IV administration sets and pump administration se... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | SafeDAY set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Blood Administration Set utilized in gravity IV administration sets and pump ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Burette Set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | CARESAFE utilized in gravity IV administration sets and pump administration s... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | ULTRASITE set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Caresite utilized in gravity IV administration sets and pump administration s... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk | Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. | Class II | Copan Italia |
| Oct 29, 2025 | Outlook set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the i... | Class II | Medicrea International |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Outlook set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | RATE FLOW set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
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.