Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 151 of 548
FDA Devices Moderate Jun 1, 2022
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Olympus Corporation of the Americas
FDA Devices Moderate Jun 1, 2022
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include t…
Accriva Diagnostics, Inc.
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
Beckman Coulter Inc.
FDA Devices Moderate May 25, 2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc.
FDA Devices Moderate May 25, 2022
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Beckman Coulter Inc.
FDA Devices Moderate May 25, 2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Luminex Corporation
FDA Devices Moderate May 25, 2022
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, …
Radiometer Medical ApS
FDA Devices Moderate May 25, 2022
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Table…
Total Resources Intl
FDA Devices Moderate May 25, 2022
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Baxter Healthcare Corporation
FDA Devices Moderate May 25, 2022
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Beckman Coulter Inc.
FDA Devices Moderate May 25, 2022
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Ortho-Clinical Diagnostics, Inc
FDA Devices Moderate May 25, 2022
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Getinge Usa Sales Inc
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Heartware, Inc.
FDA Devices Moderate May 25, 2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories, Inc.
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Heartware, Inc.
FDA Devices Moderate May 25, 2022
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction o…
Clinician's Choice Dental Products Inc.
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Heartware, Inc.
FDA Devices Moderate May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
Boston Scientific Corporation
FDA Devices Critical May 25, 2022
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 8…
Atrium Medical Corporation
FDA Devices Critical May 25, 2022
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 8…
Atrium Medical Corporation
FDA Devices Moderate May 25, 2022
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Ortho-Clinical Diagnostics, Inc
FDA Devices Moderate May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
Boston Scientific Corporation
FDA Devices Low May 25, 2022
CK MB Calibrator, Catalogue Number CK2393
Randox Laboratories Ltd.
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Heartware, Inc.
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergenc…
Heartware, Inc.
FDA Devices Moderate May 25, 2022
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wit…
Boston Scientific Corporation
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Heartware, Inc.
FDA Devices Moderate May 18, 2022
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible …
Karl Storz Endoscopy
FDA Devices Critical May 18, 2022
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Woodside Acquisitions Inc.
FDA Devices Moderate May 18, 2022
VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux, Inc.
FDA Devices Moderate May 18, 2022
BF-3C160: EVIS EXERA Bronchovideoscope
Olympus Corporation of the Americas
FDA Devices Moderate May 18, 2022
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
PROTERIXBIO
FDA Devices Moderate May 18, 2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm.…
Synthes (USA) Products LLC
FDA Devices Moderate May 18, 2022
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Olympus Corporation of the Americas
FDA Devices Moderate May 18, 2022
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular, Inc.
FDA Devices Moderate May 18, 2022
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU…
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope…
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory
FDA Devices Critical May 18, 2022
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Woodside Acquisitions Inc.
FDA Devices Moderate May 18, 2022
ACS Cath Lab Pack
American Contract Systems, Inc.
FDA Devices Moderate May 18, 2022
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US;…
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
BF-MP60: OES Bronchofiberscope
Olympus Corporation of the Americas
FDA Devices Moderate May 18, 2022
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z…
Karl Storz Endoscopy
FDA Devices Moderate May 18, 2022
ACS Lap Chole Pack
American Contract Systems, Inc.
FDA Devices Moderate May 18, 2022
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-…
Ethicon, Inc.
FDA Devices Moderate May 18, 2022
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Olympus Corporation of the Americas
FDA Devices Moderate May 18, 2022
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
SIMPLIVIA HEALTHCARE LTD.
FDA Devices Moderate May 18, 2022
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodyna…
Philips North America Llc
FDA Devices Moderate May 18, 2022
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z…
Karl Storz Endoscopy