Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 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 437 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 7, 2013	00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 0...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 0...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 0059...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Fem...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 0059...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 0059720612...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femu...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 905...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-F...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 005970...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Ster...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
May 23, 2013	Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00...	This is a recall expansion from the 2010 recall which now includes seven additional lots that wer...	Class II	Zimmer, Inc.
May 23, 2013	Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 430...	This is a recall expansion from the 2010 recall which now includes seven additional lots that wer...	Class II	Zimmer, Inc.
Mar 27, 2013	NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. U...	Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the p...	Class II	Zimmer, Inc.
Feb 14, 2013	Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter ass...	The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting b...	Class II	Zimmer, Inc.
Feb 8, 2013	Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ...	Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s...	Class II	Zimmer, Inc.
Nov 19, 2012	Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regula...	Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn...	Class II	Zimmer, Inc.
Nov 19, 2012	COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS ...	Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 m...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, ...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, ...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diame...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 14, 2012	Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, ...	All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ...	Class II	Zimmer, Inc.
Nov 12, 2012	Zimmer Spine Ardis Inserter, Rx, non-sterile	Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when...	Class I	Zimmer, Inc.
Sep 21, 2012	NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The N...	Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component...	Class II	Zimmer, Inc.
Sep 20, 2012	The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non ...	Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the...	Class II	Zimmer, Inc.
Sep 20, 2012	The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. S...	Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missin...	Class II	Zimmer, Inc.
Sep 14, 2012	Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	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.