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 |
|---|---|---|---|---|
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| May 20, 2026 | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guid... | Five complaints have been received identifying issues where the plastic guides were catching duri... | Class II | Zimmer, Inc. |
| May 20, 2026 | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide... | Five complaints have been received identifying issues where the plastic guides were catching duri... | Class II | Zimmer, Inc. |
| May 20, 2026 | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog ... | Five complaints have been received identifying issues where the plastic guides were catching duri... | Class II | Zimmer, Inc. |
| May 20, 2026 | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog... | Five complaints have been received identifying issues where the plastic guides were catching duri... | Class II | Zimmer, Inc. |
| May 20, 2026 | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Gui... | Five complaints have been received identifying issues where the plastic guides were catching duri... | Class II | Zimmer, Inc. |
| May 11, 2026 | Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Meta... | Firm received a complaint with no clinical impact in which a posterior augment was found within t... | Class II | Zimmer, Inc. |
| Apr 2, 2026 | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Mar 30, 2026 | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... | Ten complaints have been received identifying issues at the time of use related to the package se... | Class II | Zimmer, Inc. |
| Mar 5, 2026 | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Jan 20, 2026 | cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, 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.