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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 22, 2020 | smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 22, 2020 | smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 22, 2020 | smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manu... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 22, 2020 | smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 22, 2020 | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in ... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 22, 2020 | smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Class II | Smith & Nephew, Inc. |
| Apr 9, 2020 | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Prod... | One lot of INBONE Tibial Trays is missing the plasma coating. | Class II | Wright Medical Technology Inc |
| Mar 26, 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 27, 2020 | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF ... | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanica... | Class II | DeRoyal Industries Inc |
| Feb 27, 2020 | NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissu... | Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraopera... | Class II | Smith & Nephew, Inc. |
| Feb 6, 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included... | The sterile packaging has the potential to be compromised. | Class II | Deroyal Industries, Inc. Lafollette |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... | Class II | Deroyal Industries, Inc. Lafollette |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... | Class II | Deroyal Industries, Inc. Lafollette |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... | Class II | Deroyal Industries, Inc. Lafollette |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... | Class II | Deroyal Industries, Inc. Lafollette |
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.