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.

Date	Product	Reason	Class	Firm
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 20, 2024	ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate...	Thread form issue for the locking holes in that the locking screws may not properly mate with the...	Class II	Zimmer, Inc.
Mar 13, 2024	Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb...	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro...	Class II	Biomet, Inc.
Mar 12, 2024	ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co...	Product incorrectly labelled.	Class II	DePuy Orthopaedics, Inc.
Mar 1, 2024	Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Trocar Needle - Used for dilating puncture sites or catheter tracts for percu...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Dilator - Intended to be used for dilating puncture sites or catheter tracts ...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Mar 1, 2024	Peel-Away Introducer - Intended for the percutaneous introduction of balloon,...	Packaging may have low seal strength and not meet peel strength specifications, compromising devi...	Class II	Cook Incorporated
Dec 21, 2023	FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t...	Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati...	Class II	G & H Wire Company
Dec 7, 2023	MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb...	The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ...	Class II	Cook Medical Llc
Nov 2, 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01	One product complaint was received reporting that there was an incorrect adapter in the packaging...	Class II	Biomet, Inc.
Nov 2, 2023	Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02	One product complaint was received reporting that there was an incorrect adapter in the packaging...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of u...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccess...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of un...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 9, 2023	Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsucc...	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d...	Class II	Biomet, Inc.
Oct 3, 2023	Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,...	Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma sa...	Class II	Roche Diagnostics Operations, Inc.
Jul 26, 2023	M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item N...	The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, a...	Class II	Zimmer, Inc.
Jun 27, 2023	Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole...	Thread form issue of the locking holes in that the locking screws would not properly mate with th...	Class II	Zimmer, Inc.
May 19, 2023	NexGen Precoat Stemmed Tibial Plate Size 5	Device outer packaging was incorrectly labeled.	Class II	Zimmer, Inc.
Apr 7, 2023	Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ...	There were reports from customers that the tracheostomy in the sets and trays is not making a sec...	Class I	Cook Incorporated
Apr 7, 2023	Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part...	There were reports from customers that the tracheostomy in the sets and trays is not making a sec...	Class I	Cook Incorporated
Feb 27, 2023	CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he...	Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem...	Class II	Zimmer, Inc.
Feb 15, 2023	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part N...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part N...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, 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.