Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 031836... | Roche received several complaints regarding increased control recovery and discrepant elevated re... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatog... | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not author... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 26, 2021 | REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 23, 2021 | Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 23, 2021 | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated ... | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 23, 2021 | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornice... | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead ... | Class II | CooperSurgical, Inc. |
| Apr 23, 2021 | Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... | Due to issue with product sterility. Sterilization service provider had falsified records. | Class II | Adler MicroMed, Inc. |
| Apr 23, 2021 | Synaptive Trackable Suction Set Standard and Malleable | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. | Class II | Synaptive Medical Inc |
| Apr 22, 2021 | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/pack... | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. | Class II | Remel Inc |
| Apr 22, 2021 | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount m... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Apr 22, 2021 | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall ... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Apr 22, 2021 | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 | Potential capacitor failure which typically manifests as in inability to provide output on one or... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 21, 2021 | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr... | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E... | Class II | Boston Scientific Corporation |
| Apr 21, 2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... | Class II | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Apr 21, 2021 | Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagno... | Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This ca... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 21, 2021 | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ... | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. | Class II | Anodyne Surgical |
| Apr 21, 2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling which has some differ... | Class III | MICROVENTION INC. |
| Apr 21, 2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with e... | IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duo... | Class II | Pentax of America Inc |
| Apr 21, 2021 | Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination b... | Removing parts for safety reasons due to possible breakage. | Class II | Dentech Corp. |
| Apr 21, 2021 | RAPTAR Laser Range Finders | RAPTAR units are capable of being field modified to enable the use of the higher power visible an... | Class II | Potomac River Group, Corp. |
| Apr 21, 2021 | RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 ... | Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after ... | Class II | RAYSEARCH LABORATORIES AB |
| Apr 20, 2021 | Logical cup liner - Product Usage: intended to replace a hip joint where bone... | Product mislabeled, with the incorrect product inside the package. | Class II | Signature Orthopedics Pty Limited |
| Apr 20, 2021 | Multitom RAX with software version VF10 | Siemens identified two issues, In some cases, it is possible to perform an image acquisition alth... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2021 | Alpha Interlock Suspension System Lanyard Body: An external prosthetic device... | the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8... | Class II | WillowWood Global Llc |
| Apr 20, 2021 | Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, ... | Malware attack | Class II | Elekta, Inc. |
| Apr 20, 2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in c... | The lot may have experienced an anomaly during the manufacturing process, that could lead to an o... | Class II | Medivators, Inc. |
| Apr 19, 2021 | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic... | If a certain sequence of events occur, the pdf test report that belongs to one patient will appea... | Class II | GE Healthcare, LLC |
| Apr 19, 2021 | Econocare Plus Waffle Overlay- Intended for use as a medical device to aid i... | Product contamination-a trace amount of dried bodily fluids may expose patients, health care prov... | Class II | EHOB, Inc. |
| Apr 19, 2021 | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682... | The IGS system can experience a single vertical line defect where the vertical line divides and h... | Class II | GE Healthcare, LLC |
| Apr 19, 2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with... | A software defect was identified where the Image Styles defined by presentation states from CHRS ... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Apr 16, 2021 | The Terumo HX2 Temperature Management System provides temperature control of ... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 | Elevated rates of false positive/false negative and control failures while using the Pneumonia Pa... | Class II | BioFire Diagnostics, LLC |
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.