Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 203 of 548
FDA Devices Moderate Oct 7, 2020
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP100…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to huma…
Zeus Scientific, Inc.
FDA Devices Moderate Oct 7, 2020
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: i…
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product Usage:…
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage:…
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage: indi…
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: B…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Det…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have…
Covidien, LP
FDA Devices Moderate Oct 7, 2020
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.",…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have appl…
Covidien, LP
FDA Devices Moderate Oct 7, 2020
Control, Calibrator Verified, Triage BNP, Model ALR88755
Medline Industries Inc
FDA Devices Moderate Oct 7, 2020
AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ult…
ESAOTE S.P.A
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in s…
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in …
Riverpoint Medical, LLC
FDA Devices Moderate Oct 7, 2020
Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC…
Ameditech Inc
FDA Devices Moderate Oct 7, 2020
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage…
Riverpoint Medical, LLC
FDA Devices Moderate Sep 30, 2020
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that per…
Beckman Coulter Biomedical GmbH
FDA Devices Moderate Sep 30, 2020
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
ArthroCare Corporation
FDA Devices Critical Sep 30, 2020
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
MicroPort Orthopedics Inc.
FDA Devices Moderate Sep 30, 2020
Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a componen…
Sorin Group Italia S.r.l.
FDA Devices Moderate Sep 30, 2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology ca…
Irvine Biomedical Inc, a St. Jude Medical Co.
FDA Devices Moderate Sep 30, 2020
NM/CT 850 Model Number: H3907AD
GE Healthcare, LLC
FDA Devices Low Sep 30, 2020
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of S…
DNA Genotek Inc.
FDA Devices Moderate Sep 30, 2020
Central Line Dressing Change Tray
Medline Industries Inc
FDA Devices Moderate Sep 30, 2020
Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a componen…
Sorin Group Italia S.r.l.
FDA Devices Moderate Sep 30, 2020
Discovery NM 630 Model # H3101RH
GE Healthcare, LLC
FDA Devices Moderate Sep 30, 2020
Speed Stitch Needle Cassette
ArthroCare Corporation
FDA Devices Moderate Sep 30, 2020
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of …
Sorin Group Italia S.r.l.
FDA Devices Moderate Sep 30, 2020
EVOLVE STEM 8.5MM Model # 496S085
Wright Medical Technology Inc
FDA Devices Moderate Sep 30, 2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology ca…
Irvine Biomedical Inc, a St. Jude Medical Co.
FDA Devices Moderate Sep 30, 2020
Discovery NM670 Pro Model # H3100XB
GE Healthcare, LLC
FDA Devices Moderate Sep 23, 2020
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Cal…
Tosoh Bioscience Inc
FDA Devices Moderate Sep 23, 2020
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J0200…
Imactis
FDA Devices Low Sep 23, 2020
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a met…
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Sep 23, 2020
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platfor…
Life Technologies Corporation
FDA Devices Moderate Sep 23, 2020
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. T…
Integra LifeSciences Corp.
FDA Devices Moderate Sep 23, 2020
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydr…
Randox Laboratories Ltd.
FDA Devices Moderate Sep 23, 2020
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate…
Randox Laboratories Ltd.
FDA Devices Moderate Sep 23, 2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cut…
Integra LifeSciences Corp.
FDA Devices Moderate Sep 23, 2020
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aort…
Cook Inc.
FDA Devices Moderate Sep 23, 2020
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
Avanos Medical, Inc.
FDA Devices Moderate Sep 23, 2020
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN…
Tosoh Bioscience Inc
FDA Devices Moderate Sep 23, 2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand …
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Sep 23, 2020
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intend…
Inpeco S.A.
FDA Devices Moderate Sep 23, 2020
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intend…
Inpeco S.A.
FDA Devices Moderate Sep 23, 2020
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous o…
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Sep 23, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medtronic Inc.