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.

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DateProductReasonClassFirm
Feb 1, 2021 Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Due to software defect, under certain assay parameters, false Vitamin D results may be reported. ... Class II Thermo Fisher Scientific
Feb 1, 2021 Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter ... Outer coating of the catheter may deteriorate and result in the coating to crack and/or potential... Class II Epimed International, Inc.
Feb 1, 2021 ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for c... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalo... Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery an... Class II Insulet Corporation
Jan 29, 2021 VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Numbe... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma... Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emer... Class II Confirm Biosciences Inc
Jan 29, 2021 Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF G... Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emer... Class II Confirm Biosciences Inc
Jan 29, 2021 VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Nu... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 29, 2021 S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133... The manufacturer has become aware that there is a likelihood that the S-Series Equipment Manageme... Class II Stryker Communications
Jan 29, 2021 Anesthesia gas-machine - Product Usage: intended for use in administering ane... Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zer... Class II Getinge Group Logistics America, LLC
Jan 29, 2021 ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Numb... Y-piece may become detached from the ventilation hose either before or during the ventilation pro... Class II Draeger Medical, Inc.
Jan 28, 2021 Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replaceme... Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... Class II Baxter Healthcare Corporation
Jan 28, 2021 VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext... bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... Class II Biomerieux Inc
Jan 28, 2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class III OriGen Biomedical, Inc.
Jan 28, 2021 Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G50... Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... Class II Baxter Healthcare Corporation
Jan 28, 2021 Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... Class II Baxter Healthcare Corporation
Jan 28, 2021 VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with... bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... Class II Biomerieux Inc
Jan 28, 2021 Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacemen... Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repos... Class II Baxter Healthcare Corporation
Jan 28, 2021 Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Ol... Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated w... Class II Olympus Corporation of the Americas
Jan 27, 2021 Sensis / Sensis Vibe systems with software version VD12 and equipped with HP ... System may sporadically freeze (lock-up) during operation or while being in an idle state, no lon... Class II Siemens Medical Solutions USA, Inc
Jan 27, 2021 TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product ... Due to the release of nonconforming Intraocular Lenses (IOLs). Class II Johnson & Johnson Surgical Vision Inc
Jan 26, 2021 BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 0081538102033... The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID... Class II BioFire Diagnostics, LLC
Jan 26, 2021 Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood C... The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID... Class II BioFire Diagnostics, LLC
Jan 25, 2021 Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01)... There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded ... Class II Shanghai United Imaging Healthcare Co., Ltd.
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 25, 2021 RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: mon... Product was compromised during shipment. Class II Medline Industries Inc
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 22, 2021 Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will ... Class II Barco N.V.
Jan 22, 2021 ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U... Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section... Class I Acist Medical Systems
Jan 22, 2021 Radiation therapy software, RayStation standalone software treatment planning... A software bug affecting results when using deep learning (DL) segmentation followed by geometric... Class II RaySearch America Inc
Jan 21, 2021 Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/S... The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), in... Class II CooperSurgical, Inc.
Jan 21, 2021 OT1000 Series Orthopedic Surgical Tables On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assem... Class II Steris Corporation
Jan 21, 2021 Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... Class II G & H Wire Company
Jan 20, 2021 Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR imm... R&D Systems, Inc. received two complaints that the standard signal was low and controls were not ... Class II R & D Systems, Inc.
Jan 19, 2021 HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consis... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, Inc.
Jan 19, 2021 Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consi... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, Inc.
Jan 19, 2021 Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthr... Non-sterile product was shipped to customers labelled as sterile. Class II ReNovo, Inc.
Jan 19, 2021 Enteral Infusion Pump The potential for air appearing in the enteral feed pumping set tubing during set-up. Class II Cardinal Health 200, LLC
Jan 19, 2021 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... Class II Boston Scientific Corporation
Jan 19, 2021 Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmon... Product was distributed without receiving regulatory clearance. Class II Stryker Sustainability Solutions
Jan 19, 2021 AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnost... Distributed COVID test kits without emergency use authorization. Class II Sky Medical Supplies and Equipments LLC
Jan 18, 2021 Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend... Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless Fle... Class II Smiths Medical ASD Inc.
Jan 15, 2021 S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... Class III Medline 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.