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 |
|---|---|---|---|---|
| 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.