Browse Device Recalls
1,125 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,125 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 1,125 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For ... | There is a potential for intermittent cracks in the raw material batch used to produce the affect... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 F... | There is a potential for intermittent cracks in the raw material batch used to produce the affect... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For u... | There is a potential for intermittent cracks in the raw material batch used to produce the affect... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, 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.