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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
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 22, 2017 PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH,... This lot of left plates were laser etched and packaged as right plates. 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 20, 2017 Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs... The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class II Siemens Medical Solutions USA Inc.
Feb 20, 2017 Poly Component Trial, MPCS, packaged in the following sizes and configuration... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Poly Component Trial, PS, packaged in the following sizes and configurations:... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mo... The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class II Siemens Medical Solutions USA Inc.
Feb 20, 2017 Poly Component Trial, CR, packaged in the following sizes and configurations:... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs... The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class II Siemens Medical Solutions USA Inc.
Feb 20, 2017 Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile P... The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. Class II Siemens Medical Solutions USA Inc.
Feb 20, 2017 Poly Component Trial, UCCS, packaged in the following sizes and configuration... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 16, 2017 MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1... Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 1... Class II Crossroads Extremity Systems Llc
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.
Jan 25, 2017 SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI... DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... Class III DeRoyal Industries Inc
Jan 25, 2017 DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W... DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... Class III DeRoyal Industries Inc
Dec 13, 2016 Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Bi... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mC... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT ... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Bi... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT an... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biogra... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 13, 2016 Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph... Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some las... Class II Siemens Medical Solutions USA Inc.
Dec 7, 2016 Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... Damaged packaging, lack of sterility assurance Class II Medacta Usa Inc
Nov 29, 2016 symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C1313... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C1... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 17, 2016 PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Ortho... The recall is being initiated because all broach handles in the affected lot had the same non-con... Class II MicroPort Orthopedics 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 8, 2016 SWANSON FINGER JOINT #2, Part Number 4700002 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number ... The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, 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.