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Browse Device Recalls

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls in TN.

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DateProductReasonClassFirm
Apr 25, 2016 Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemen... The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoin... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph True... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph T... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePo... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Bio... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens ... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biogr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Bi... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph Tr... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biog... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TrueP... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemen... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA Inc.
Apr 22, 2016 BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph Tru... Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... Class II Siemens Medical Solutions USA 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.

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.