Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 5, 2021 | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The... | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patie... | Class II | Dignitana, Inc. |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | The package contents and package labeling do not match. | Class II | Wright Medical Technology Inc |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS | The package contents and package labeling do not match. | Class II | Wright Medical Technology Inc |
| Oct 29, 2021 | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity ... | M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2... | Class II | Diversatek Healthcare |
| 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. |
| Oct 20, 2021 | Aspiration Syringe Kit, REF: MVSK60 | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. | Class II | MICROVENTION INC. |
| Oct 14, 2021 | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... | Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... | Class III | Cardiac Assist, Inc |
| Oct 14, 2021 | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Nu... | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become... | Class II | Hill-Rom Inc. |
| Oct 12, 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and ... | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | Class II | Medtronic Perfusion Systems |
| Oct 11, 2021 | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual... | Class II | Jjgc Industria E Comercio De Materials Dentario... |
| Oct 7, 2021 | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 | Mislabeled product. | Class II | SCIENCE & BIO MATERIALS |
| Oct 1, 2021 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Oct 1, 2021 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 22, 2021 | ProxiDiagnost N90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | CombiDiagnost R90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 21, 2021 | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of th... | Incorrect expiration date on its package labeling (shipper box and inner carton label). | Class II | Intuitive Surgical, 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 14, 2021 | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr... | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist &... | Class II | Bayer Medical Care, Inc. |
| Sep 13, 2021 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... | There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... | Class II | Medtronic Perfusion Systems |
| Sep 10, 2021 | Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) | The belt may fail at lower loads than the labeled 600lbs. | Class II | Kinsman Enterprises Inc |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 8, 2021 | Kit: Central Line Dres Change 20/Cs | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. | Class II | Medical Action Industries, Inc. 306 |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 7, 2021 | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E... | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, howe... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| 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 | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, 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 |
| Sep 2, 2021 | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a.... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Produ... | The product package may potentially contain a mismatched graft that does not contain the radial s... | Class II | Atrium Medical Corporation |
| Aug 20, 2021 | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | Primary packaging labeling may be incorrect. | Class II | ConvaTec, Inc |
| Aug 16, 2021 | BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
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.