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
Nov 25, 2020	6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 23, 2020	cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric...	During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically ...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2020	Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin c...	Device has the potential for fracture during use.	Class II	Zimmer Biomet, Inc.
Nov 17, 2020	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbos...	Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU)...	Class II	Zimmer Biomet, Inc.
Nov 6, 2020	Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa...	Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the...	Class II	Roche Diagnostics Operations, Inc.
Oct 22, 2020	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved...	Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t...	Class I	Cook Inc.
Oct 9, 2020	cobas infinity central lab/cobas infinity core license-The cobas infinity IT ...	Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira...	Class II	Roche Diagnostics Operations, 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. 22 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. 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, 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. 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. 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. 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. 22 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. 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.

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.