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Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
Jun 2, 2022 DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System u... One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or D... Class II CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Feb 14, 2022 BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Siz... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pla... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Ite... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jan 15, 2021 Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... Class II Biomet, Inc.
Dec 23, 2020 A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 23350000... The instruments may become cold welded together when the drill is inserted through the Soft Tissu... Class II Biomet, Inc.
Dec 1, 2020 Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: int... Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure Class II Biomet, Inc.
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... 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+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
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 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.

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.