Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 17, 2017	various polyethylene implants Hips Active Articulation ArComXL Bearings A...	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen...	Class II	Zimmer Biomet, Inc.
Feb 17, 2017	various polyethylene implants BIO PLUG 10MM Product Usage: Non-weig...	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen...	Class II	Zimmer Biomet, Inc.
Feb 17, 2017	various polyethylene implants Knees Revision Tibial Tray Systems Oxford P...	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen...	Class II	Zimmer Biomet, Inc.
Feb 17, 2017	various polyethylene implants Sports Med Repicci II Tibial Components P...	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen...	Class II	Zimmer Biomet, Inc.
Feb 14, 2017	Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates...	Digital templates were created with the incorrect files.	Class II	Zimmer Biomet, Inc.
Jan 10, 2017	1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, B...	The identification of the devices was non-conforming with off-centered slots and the no-go gage s...	Class II	Zimmer Biomet, Inc.
Jan 4, 2017	Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb...	packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a...	Class II	Zimmer Biomet, Inc.
Dec 20, 2016	Comprehensive Reverse Shoulder System Humeral Tray Model 115340	Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu...	Class I	Zimmer Biomet, Inc.
Dec 19, 2016	Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX...	Product complaints indicated that the part and lot numbers on the packaging differed from the phy...	Class II	Zimmer Biomet, Inc.
Dec 19, 2016	RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m...	Product complaints indicated that the part and lot numbers on the packaging differed from the phy...	Class II	Zimmer Biomet, Inc.
Dec 16, 2016	Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai...	labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ...	Class II	Zimmer Biomet, Inc.
Dec 15, 2016	Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM I...	Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to p...	Class II	Zimmer Biomet, Inc.
Dec 6, 2016	Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste...	Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis...	Class II	Zimmer Biomet, Inc.
Oct 11, 2016	ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori...	Complaint of the head holder connector locking up mechanically when tightened.	Class II	Zimmer Biomet, Inc.
Sep 28, 2016	Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece	Complaints have been reported that the handpiece is inoperable. The investigation found that the ...	Class II	Zimmer Biomet, Inc.
Aug 16, 2016	Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro...	Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor...	Class II	Zimmer Biomet, Inc.
Aug 9, 2016	Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve ...	Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch...	Class II	Zimmer Biomet, Inc.
Aug 9, 2016	Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and O...	Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch...	Class II	Zimmer Biomet, Inc.
Aug 9, 2016	Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and...	Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F...	Class II	Zimmer Biomet, Inc.
Aug 8, 2016	Vanguard 360 Revision Knee System Knee prostheses	The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolt...	Class II	Zimmer Biomet, Inc.
Aug 2, 2016	Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smoot...	The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and o...	Class II	Zimmer Biomet, Inc.
Jul 29, 2016	ROSA BRAIN 3.0.0	Non-conforming product label.	Class II	Zimmer Biomet, Inc.
Jul 20, 2016	ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin...	Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.	Class II	Zimmer Biomet, Inc.
Jun 10, 2016	TSP Hip Fracture Plating System device, fixation, proximal femoral, implant ...	The screw may fracture at the junction of the shaft and the head during implantation. The patient...	Class II	Biomet, Inc.
May 27, 2016	ROSA Brain 3.0 Intended for the spatial positioning and orientation of instr...	Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.	Class II	Zimmer Biomet, Inc.
May 11, 2016	Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Inst...	Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instrument...	Class II	Zimmer Biomet, Inc.
Apr 11, 2016	PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to acces...	The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay ...	Class II	Biomet, Inc.
Apr 8, 2016	ROSA Surgical Device 2.5.8	Potential for software to change the final tool orientation for the command position without comm...	Class II	Zimmer Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. guide, surgical...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Bit, drill.	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Passer.	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Pin, fixation, ...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Appliance, fixa...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Fastener, fixat...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Plate, fixation...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Reamer.	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. cannula, surgic...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Orthopedic manu...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Arthroscope.	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Screw, fixation...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Spinal interlam...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Apr 1, 2016	Various trauma and sports medicine instruments and implants. Rod, fixation, ...	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t...	Class II	Biomet, Inc.
Mar 9, 2016	All instrumentation associated with the Prelude PF Resurfacing Knee System.	Inadequate design control.	Class II	Biomet, Inc.
Feb 16, 2016	Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac...	Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract...	Class II	Biomet, Inc.
Feb 16, 2016	HipLOC CHS Plate/Lag Screw Introducer	A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not...	Class II	Biomet, Inc.
Feb 11, 2016	M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093	Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost...	Class II	Zimmer Biomet, Inc.
Feb 5, 2016	Vanguard XP Knee System Porous Femoral Component various sizes and orientat...	The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does...	Class II	Biomet, Inc.
Jan 29, 2016	Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi...	Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur...	Class II	Biomet, Inc.
Jan 20, 2016	Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac...	Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.	Class II	Zimmer Biomet, Inc.
Jan 11, 2016	Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-const...	LDPE bag containing the implant adheres to the highly polished implant surface.	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.