Browse Device Recalls
755 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 755 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 755 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 1, 2021 | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... | Class II | Smith & Nephew, Inc. |
| Nov 1, 2021 | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... | Class II | Smith & Nephew, Inc. |
| Nov 1, 2021 | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... | Class II | Smith & Nephew, Inc. |
| Oct 25, 2021 | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM... | The labels on the packages of screws were switched. | Class II | Smith & Nephew, Inc. |
| Sep 20, 2021 | 6.5MMX165MM CANNULATED SCREW | The product label incorrectly indicated that the screws are fully threaded, but the screws contai... | Class II | Smith & Nephew, Inc. |
| Sep 2, 2021 | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming... | DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming Syst... | Class I | Deroyal Industries, Inc. Lafollette |
| Sep 2, 2021 | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 24, 2021 | ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmissio... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | National Distribution & Contracting Inc |
| Aug 24, 2021 | ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | National Distribution & Contracting Inc |
| Aug 19, 2021 | P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 | The rear heater plate and cover assembly that contains the electrical wiring for the heaters does... | Class II | Fort Defiance Industries, LLC |
| Aug 18, 2021 | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Produc... | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. | Class II | In2bones USA, LLC |
| Jul 23, 2021 | AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 | The kit contains the wrong vial tray in the package. | Class II | BioMimetic Therapeutics, LLC |
| May 19, 2021 | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, ... | The device components experienced a manufacturing process error that resulted in surface damage f... | Class II | Smith & Nephew, Inc. |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| Apr 27, 2021 | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intende... | Product is impacted by a thread profile defect due to a manufacturing issue. | Class II | Medtronic Sofamor Danek USA, Inc |
| Mar 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys... | Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pum... | Class I | The Biomed Guys |
| Mar 17, 2021 | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... | The shelf box identifies a small device actually contains a large device, and the shelf box ident... | Class II | Medtronic Sofamor Danek USA, Inc |
| Mar 17, 2021 | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... | The shelf box identifies a small device actually contains a large device, and the shelf box ident... | Class II | Medtronic Sofamor Danek USA, Inc |
| Jan 25, 2021 | Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Jan 25, 2021 | CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Jan 25, 2021 | Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 ... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Jan 8, 2021 | 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended f... | Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirul... | Class II | Cairn Diagnostics |
| Dec 18, 2020 | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product ... | Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grai... | Class II | Smith & Nephew, Inc. |
| Dec 17, 2020 | EXOGEN Ultrasound Coupling Gel | Product may contain white particulates that are microbial in nature. | Class II | Bioventus, LLC |
| Nov 2, 2020 | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... | Manufacturing packaging error. | Class II | Smith & Nephew, Inc. |
| Sep 21, 2020 | Genesis (GII) - Product Usage: designed for use in patients in primary and re... | The anterior locking detail does not meet its design specifications. | Class II | Smith & Nephew, Inc. |
| Aug 26, 2020 | EVOLVE STEM 8.5MM Model # 496S085 | Lack of sterility assurance | Class II | Wright Medical Technology Inc |
| Aug 24, 2020 | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indic... | Multiple or incorrect expiration dates were provided on the affected designation labels. | Class II | Smith & Nephew, Inc. |
| Aug 3, 2020 | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during sur... | The products were improperly heat treated. | Class II | Smith & Nephew, Inc. |
| Jul 31, 2020 | PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01... | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... | Class I | MicroPort Orthopedics Inc. |
| Jul 31, 2020 | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descripti... | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium ... | Class II | MicroPort Orthopedics Inc. |
| Jul 31, 2020 | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, ... | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... | Class I | MicroPort Orthopedics Inc. |
| Jul 28, 2020 | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medica... | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | Class II | Wright Medical Technology, Inc. |
| Jul 28, 2020 | Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright... | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | Class II | Wright Medical Technology, Inc. |
| Jul 16, 2020 | Tibial knee prosthesis | Due to an inconsistency in the raw material process, specific lots may contain units with interna... | Class II | Smith & Nephew, Inc. |
| Jun 29, 2020 | PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usa... | The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | Class II | Smith & Nephew, Inc. |
| Jun 24, 2020 | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistanc... | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight p... | Class II | Smith & Nephew, Inc. |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF... | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled... | Class II | DeRoyal Industries 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.