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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Date	Product	Reason	Class	Firm
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 24, 2020	ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ...	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t...	Class II	Zimmer Biomet, Inc.
Sep 4, 2020	Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050	Product not properly being aligned with the adequate gamma sterilization group and result in the...	Class II	Biomet, Inc.
Sep 4, 2020	Biomet Regenerex Primary Taper Cap Item Number 141269	Product not properly being aligned with the adequate gamma sterilization group and result in the...	Class II	Biomet, Inc.
Sep 4, 2020	Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055	Product not properly being aligned with the adequate gamma sterilization group and result in the...	Class II	Biomet, Inc.
Sep 4, 2020	Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055	Product not properly being aligned with the adequate gamma sterilization group and result in the...	Class II	Biomet, Inc.
Sep 3, 2020	(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar C...	Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip sy...	Class II	Biomet, Inc.
Sep 2, 2020	Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper A...	Product potentially being packaged without a taper adapter or baseplate. The package should conta...	Class II	Biomet, Inc.
Aug 31, 2020	Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, ...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 31, 2020	Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-...	The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ...	Class II	Cook Inc.
Aug 31, 2020	BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001	Potential for Fluid leaks within the instruments, creating an electrical short inside the power s...	Class II	Roche Diagnostics Operations, Inc.
Aug 31, 2020	DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Nu...	Potential for Fluid leaks within the instruments, creating an electrical short inside the power s...	Class II	Roche Diagnostics Operations, Inc.
Aug 27, 2020	Tina-quant Complement C4 ver.2, Catalog 05991994190	Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for...	Class III	Roche Diagnostics Operations, Inc.
Aug 27, 2020	Albumin Gen.2, Catalog 05166861190	Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for...	Class III	Roche Diagnostics Operations, Inc.
Aug 20, 2020	Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 063...	Recent internal verification studies found the current RF interference claim to no longer be met ...	Class II	Roche Diagnostics Operations, Inc.
Aug 14, 2020	Dual Mobility Vivacit-E Bearing, Model Number 110031009	The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size...	Class II	Zimmer Biomet, Inc.
Aug 11, 2020	Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated ...	May contain excess glue within the handle of the delivery system, resulting in an inability to fu...	Class II	Cook Inc.
Jul 30, 2020	Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Numb...	Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa ...	Class II	Cook Inc.
Jul 6, 2020	Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 S...	Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have ...	Class II	OrthoPediatrics Corp
Jun 30, 2020	Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used ...	Affected beds may have screws installed that do not meet material tensile strength requirements. ...	Class II	Hill-Rom, Inc.
Jun 30, 2020	Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to trea...	Affected beds may have screws installed that do not meet material tensile strength requirements. ...	Class II	Hill-Rom, Inc.
Jun 9, 2020	Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE O...	QC inspection observed that a portion of the lot may have been contaminated with blood.	Class II	EHOB, Inc.
Jun 5, 2020	OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod...	ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec...	Class II	OrthoPediatrics Corp
Jun 5, 2020	OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod...	ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec...	Class II	OrthoPediatrics Corp
Jun 2, 2020	Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usag...	Identified products may contain a damaged bushing within the delivery system, which could potenti...	Class II	Cook Inc.
May 11, 2020	Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01...	The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS...	Class II	Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Num...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number ...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Num...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Num...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	Class II	Zimmer Biomet, Inc.
May 5, 2020	Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Nu...	There are reports of inadequate locking of the extended tab screws. Complaints were reported whe...	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.