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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
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.
Nov 26, 2025 Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 26, 2025 Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... Cook Medical identified that products supplied in the affected device lots may have been manufact... Class II Cook Incorporated
Nov 21, 2025 The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit... Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. ... Class II Roche Diagnostics Operations, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 23, 2025 BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Numbe... There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint... Class II Biomet, Inc.
Sep 18, 2025 Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... Class I Cook Medical Incorporated
Sep 9, 2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... Class II Biomet, Inc.
May 15, 2025 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... Cook Medical identified that catheters supplied in the affected device lots may experience tip se... Class I Cook Incorporated
Apr 17, 2025 Tornado Embolization Microcoil, intended for embolization of selective vessel... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Feb 27, 2025 NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... Class II Zimmer, Inc.
Feb 12, 2025 Z1 Femoral Hip System, Product Number 611777612 There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the d... Class II Zimmer, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Nov 22, 2024 Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Ste... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Oct 21, 2024 JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 Firm received complaints reporting that guides were warped when pulled out of packaging. This iss... Class II Biomet, Inc.
Oct 17, 2024 cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Ass... Class II Roche Diagnostics Operations, Inc.
Oct 14, 2024 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Devices from the affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Sep 26, 2024 KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, 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.