Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-06-01FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus DISPOSABLE GRASPING FORCEPS, FG-51D
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
- 2022-06-01FDA-DeviceAccriva Diagnostics, Inc.Class IIThe VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.
- 2022-06-01FDA-DeviceInternational Science & Technology, LP, DBA Diamatrix Ltd.Class IIOuter Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel
Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".
- 2022-06-01FDA-DeviceSteris CorporationClass IIUltra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Product not approved for release for US distribution
- 2022-06-01FDA-DeviceSteris CorporationClass IIUltra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Product not approved for release for US distribution
- 2022-06-01FDA-DeviceARJOHUNTLEIGH POLSKA Sp. z.o.o.Class ISara Plus Active Floor Lift
The device may emit smoke or ignite.
- 2022-05-25FDA-DeviceCaire, Inc.Class IICAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
The device was not cleared for U.S. distribution.
- 2022-05-25FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Uretero-reno videoscope, Model No. URF-V2
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
- 2022-05-25FDA-DeviceRadiometer Medical ApSClass IIRadiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
- 2022-05-25FDA-DeviceOrtho-Clinical Diagnostics, IncClass IIVITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
- 2022-05-25FDA-DeviceOrtho-Clinical Diagnostics, IncClass IIVITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
- 2022-05-25FDA-DeviceOrtho-Clinical Diagnostics, IncClass IIVITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
- 2022-05-25FDA-DeviceTURBETT SURGICAL, LLCClass IITurbett Surgical Container, TS1500
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
- 2022-05-25FDA-DeviceMedtronic IncClass IIInstructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceLuminex CorporationClass IIVERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- 2022-05-25FDA-DeviceCooperSurgical, Inc.Class IIVITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ S
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceHeartware, Inc.Class IIHeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-05-25FDA-DeviceWindstone Medical Packaging, Inc.Class IIPrevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tr
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.
- 2022-05-25FDA-DeviceClinician's Choice Dental Products Inc.Class IIAffinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
- 2022-05-25FDA-DeviceSmith & Nephew IncClass IILEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
- 2022-05-25FDA-DeviceRandox Laboratories Ltd.Class IIICK MB Calibrator, Catalogue Number CK2393
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
- 2022-05-25FDA-DeviceBio-Rad Laboratories, Inc.Class IIBioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
- 2022-05-25FDA-DeviceAbbott VascularClass IDragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
There is a potential that the proximal marker may separate from the imaging catheter
- 2022-05-25FDA-DeviceBaxter Healthcare CorporationClass IIVoalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Firm discovered a firmware memory leak with a supplier-manufactured component.
- 2022-05-25FDA-DeviceBaxter Healthcare CorporationClass IINaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Firm discovered a firmware memory leak with a supplier-manufactured component.
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