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Browse Device Recalls

278 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 278 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 278 FDA device recalls.

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DateProductReasonClassFirm
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 9, 2017 D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Ort... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R,... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Mar 9, 2017 D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: ... The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Nov 16, 2016 REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & ... The firm received complaints of cracks in the weld on the head of the mallet. In the reported ca... Class II Smith & Nephew, Inc.
Nov 15, 2016 Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are i... All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... Class II Smith & Nephew, Inc.
Nov 15, 2016 Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) ... All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... Class II Smith & Nephew, Inc.
Nov 15, 2016 Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are in... All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... Class II Smith & Nephew, Inc.
Nov 11, 2016 Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Inte... Lack of 510k clearance for design modification. Class II Smith & Nephew, Inc.
Nov 11, 2016 Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Sup... Lack of 510k clearance for design modification. Class II Smith & Nephew, Inc.
Aug 29, 2016 TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038,... Some Bipolar shells were manufactured with an out of specification retainer groove. Class II Smith & Nephew, Inc.
Aug 29, 2016 TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 7132... Some Bipolar shells were manufactured with an out of specification retainer groove. Class II Smith & Nephew, Inc.
Jul 21, 2016 RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta... Sterility seal integrity failures on the Renasys Sterile Transparent Film Class II Smith & Nephew, Inc.
Jul 19, 2016 Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... Sterility compromised due to breach in sterile packaging Class II Smith & Nephew, Inc.
Jul 6, 2016 SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1),... The labels correctly state that the product should be a 25mm screw, but the box contained a longe... Class II Smith & Nephew, Inc.
Jun 15, 2016 Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209... The device could be subject to breaches of its sterile packaging. Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 714... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 714... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 7142... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 7142... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 714213... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE ... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Mar 11, 2016 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R,... The Affected Devices may contain a dimensional deviation that could potentially result in the su... Class II Smith & Nephew, Inc.
Jan 18, 2016 LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SI... The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, s... Class II Smith & Nephew, Inc.
Jan 11, 2016 Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical... Blade exhibiting fracture during hip arthroscopy procedures Class II Smith & Nephew, Inc.
Nov 16, 2015 BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HE... The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birming... 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.