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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
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, 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. 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. 32 mm, ... 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. 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. 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. 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. 22mm, Ne... 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, ... 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. 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.
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.
Sep 24, 2020 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... 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. 32 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. 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. 32 mm, ... 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. 32 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. 32 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. 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, 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. 32 mm, S... 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, 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. 32 mm, ... Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... Class II Zimmer Biomet, Inc.
Sep 4, 2020 Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet Regenerex Primary Taper Cap Item Number 141269 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 3, 2020 (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar C... Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip sy... Class II Biomet, Inc.
Sep 2, 2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper A... Product potentially being packaged without a taper adapter or baseplate. The package should conta... Class II Biomet, Inc.
Aug 31, 2020 CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbe... Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 31, 2020 BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... Class II Biomet 3i, LLC
Aug 14, 2020 Dual Mobility Vivacit-E Bearing, Model Number 110031009 The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size... Class II Zimmer Biomet, Inc.
May 14, 2020 Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Ite... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 14... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Ite... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number:... Distributed to the field without having completed design history files or design transfer activities Class II Biomet
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item... Distributed to the field without having completed design history files or design transfer activities Class II Biomet

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.