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Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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DateProductReasonClassFirm
Feb 22, 2021 The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 1, 2021 HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutt... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for c... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 19, 2021 Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 11, 2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro... The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class II C.R. Bard, Inc.
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & Company
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 10, 2020 CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Nov 10, 2020 CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Nov 2, 2020 Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... Manufacturing packaging error. Class II Smith & Nephew, Inc.
Oct 23, 2020 PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus... Class II Ethicon, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, 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.