Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 143 of 548
FDA Devices Moderate Sep 14, 2022
Various convenience packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
D&C pack
American Contract Systems, Inc.
FDA Devices Critical Sep 14, 2022
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory…
Philips Respironics, Inc.
FDA Devices Moderate Sep 14, 2022
Various Port Insertion Packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Various ob/gyn packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Datascope Corporation
FDA Devices Moderate Sep 14, 2022
Various eye packs, cataract packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 n…
MERCHSOURCE LLC
FDA Devices Moderate Sep 14, 2022
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Sep 14, 2022
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0…
ICU Medical, Inc.
FDA Devices Critical Sep 14, 2022
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (O…
Philips Respironics, Inc.
FDA Devices Moderate Sep 14, 2022
Various neurology packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
Various Pacemaker Packs, Cardio Thoracic Packs
American Contract Systems, Inc.
FDA Devices Critical Sep 14, 2022
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne…
Philips Respironics, Inc.
FDA Devices Moderate Sep 14, 2022
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
OrthoPediatrics Corp
FDA Devices Moderate Sep 14, 2022
Medline CHEST TUBE REORDER NO: DYNJ36762A
Medline Industries Inc.
FDA Devices Moderate Sep 14, 2022
Various ENT Packs
American Contract Systems, Inc.
FDA Devices Moderate Sep 14, 2022
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Sep 14, 2022
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Datascope Corporation
FDA Devices Moderate Sep 14, 2022
Various Angiography/Cath Lab packs/trays
American Contract Systems, Inc.
FDA Devices Moderate Sep 7, 2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral sp…
Aesculap Implant Systems LLC
FDA Devices Moderate Sep 7, 2022
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Oculus Optikgeraete GMBH
FDA Devices Moderate Sep 7, 2022
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
DeRoyal Industries Inc
FDA Devices Moderate Sep 7, 2022
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 7, 2022
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Abbott Laboratories
FDA Devices Moderate Sep 7, 2022
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
bioMerieux, Inc.
FDA Devices Moderate Sep 7, 2022
T-Cell Xtend REF TTK.610 US
OXFORD IMMUNOTEC LTD
FDA Devices Moderate Sep 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. Th…
Boston Scientific Corporation
FDA Devices Moderate Sep 7, 2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 7, 2022
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Qiagen Sciences LLC
FDA Devices Moderate Sep 7, 2022
DigitalDiagnost C50 1.1
Philips North America Llc
FDA Devices Moderate Sep 7, 2022
AggreGuide A-100 Instrument
Aggredyne, Inc.
FDA Devices Moderate Sep 7, 2022
T-SPOT.TB REF TB.300 US
OXFORD IMMUNOTEC LTD
FDA Devices Moderate Sep 7, 2022
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Canon Medical System, USA, INC.
FDA Devices Moderate Sep 7, 2022
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm RE…
New Standard Device Inc
FDA Devices Critical Sep 7, 2022
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Medtronic Xomed, Inc.
FDA Devices Moderate Sep 7, 2022
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Qiagen Sciences LLC
FDA Devices Critical Sep 7, 2022
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Medtronic Xomed, Inc.
FDA Drug Moderate Aug 31, 2022
BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 …
Family Dollar Stores, Llc.
FDA Drug Moderate Aug 31, 2022
SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL O…
Family Dollar Stores, Llc.
FDA Devices Moderate Aug 31, 2022
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. …
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Aug 31, 2022
FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Aug 31, 2022
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Aug 31, 2022
EVIS EXERA III Bronchovideoscope
Aizu Olympus Co., Ltd.
FDA Devices Moderate Aug 31, 2022
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Baxter Healthcare Corporation
FDA Devices Moderate Aug 31, 2022
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Aug 31, 2022
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult pat…
Getinge Usa Sales Inc
FDA Devices Moderate Aug 31, 2022
Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Aug 31, 2022
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multi…
Baxter Healthcare Corporation
FDA Devices Moderate Aug 31, 2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Nobel Biocare