Browse Device Recalls
2,560 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,560 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 2,560 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 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 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 | Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 ... | 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 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 | Affixus Hip Fracture Nail, LH 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 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 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 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, LH 125 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, 125 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 3, 2017 | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage:... | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on... | Class II | OrthoPediatrics Corp |
| Aug 1, 2017 | Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... | The products being recalled exceeded the weight previously tested leading to a possibility of dam... | Class II | Zimmer Biomet, Inc. |
| Aug 1, 2017 | Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT... | The products being recalled exceeded the weight previously tested leading to a possibility of dam... | Class II | Zimmer Biomet, Inc. |
| Jul 31, 2017 | Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregn... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 31, 2017 | Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 31, 2017 | Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 31, 2017 | Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 31, 2017 | Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 28, 2017 | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... | A software failure may incorrectly set the system settings to "default" settings, creating a risk... | Class II | Roche Diagnostics Corporation |
| Jul 18, 2017 | cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 ... | A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series ... | Class II | Roche Diagnostics Corporation |
| Jul 18, 2017 | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 ... | A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODU... | Class II | Roche Diagnostics Corporation |
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.