Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2022 | Turbett Surgical Container, TS1500 | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barr... | Class II | TURBETT SURGICAL, LLC |
| Apr 1, 2022 | 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/20... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 91... | Inadequate documentation verifying whether device installation has been executed in accordance wi... | Class II | Getinge Usa Sales Inc |
| Apr 1, 2022 | 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF ... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular p... | There is a potential for foreign matter. | Class II | Baxter Healthcare Corporation |
| Apr 1, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CL... | Class I | CELLTRION USA INC |
| Apr 1, 2022 | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A F... | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Apr 1, 2022 | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) | Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... | Class II | Karl Storz Endoscopy |
| Mar 31, 2022 | Olympus DISPOSABLE GRASPING FORCEPS, FG-51D | Forceps do not comply with Olympus standards for the amount of force required to open and close t... | Class II | Olympus Corporation of the Americas |
| Mar 31, 2022 | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S ... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Mar 31, 2022 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast me... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Mar 31, 2022 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Mar 30, 2022 | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, ... | There is a potential that the proximal marker may separate from the imaging catheter | Class I | Abbott Vascular |
| Mar 30, 2022 | Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... | Class II | Medtronic Inc |
| Mar 30, 2022 | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor block... | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are u... | Class II | Accriva Diagnostics, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Nu... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HV... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 30, 2022 | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the... | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | Class II | restor3d Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONIT... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Small patient labels do not match the primary device label. The primary device label accurately i... | Class II | Devicor Medical Products Inc |
| Mar 30, 2022 | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | The battery wiring harness on affected wheelchairs may become disconnected during shipment from t... | Class II | Invacare Corporation |
| Mar 30, 2022 | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Tri... | Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial C... | Class II | Howmedica Osteonics Corp. |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-2018101... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 30, 2022 | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p... | Class II | Medtronic Neuromodulation |
| Mar 29, 2022 | The device is a whole-body CT x-ray system. The acquired x-ray transmission d... | Three software issues affecting incorrect image display, error interpreting patient images due to... | Class II | Philips North America Llc |
| Mar 29, 2022 | VITEK 2 Systems and VITEK 2 with MYLA. | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and syner... | Class II | bioMerieux, Inc. |
| Mar 28, 2022 | MedMinder Medication Dispenser- Intended to serve as a medication reminder to... | Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency ... | Class II | Medminder Systems, Inc. |
| Mar 28, 2022 | Smart Toe II Intramedullary Arthrodesis Implant | The nickel-sensitivity statement on the outer carton may be partially covered by a label resultin... | Class II | Stryker GmbH |
| Mar 25, 2022 | Olympus Uretero-reno videoscope, Model No. URF-V2 | The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulatio... | Class II | Olympus Corporation of the Americas |
| Mar 25, 2022 | BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the An... | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 25, 2022 | VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 184... | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... | Class II | Ortho-Clinical Diagnostics, Inc |
| Mar 25, 2022 | Puritan Bennett 980 Series Ventilator | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display duri... | Class I | Medtronic formerly Covidien |
| Mar 25, 2022 | CK MB Calibrator, Catalogue Number CK2393 | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... | Class III | Randox Laboratories Ltd. |
| Mar 25, 2022 | VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... | Class II | Ortho-Clinical Diagnostics, Inc |
| Mar 25, 2022 | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... | Class II | Ortho-Clinical Diagnostics, Inc |
| Mar 25, 2022 | K-Wire, 1.35 mm x 170 mm | Products do not meet length and diameter specifications. | Class II | Arthrex, Inc. |
| Mar 25, 2022 | BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Ant... | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 25, 2022 | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense... | The device was not cleared for U.S. distribution. | Class II | Caire, Inc. |
| Mar 24, 2022 | STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product cod... | Affected product lots may contain the incorrect needle type/size and suture length due to compone... | Class II | Ethicon, 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.