Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 187 of 548
FDA Devices Moderate Mar 3, 2021
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the g…
Northgate Technologies, Inc.
FDA Devices Moderate Mar 3, 2021
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum sa…
DeRoyal Industries Inc
FDA Devices Moderate Mar 3, 2021
OT1000 Series Orthopedic Surgical Tables
Steris Corporation
FDA Devices Moderate Mar 3, 2021
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical proce…
DeRoyal Industries Inc
FDA Devices Moderate Mar 3, 2021
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) …
Northgate Technologies, Inc.
FDA Devices Moderate Mar 3, 2021
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surge…
Ecolab Inc
FDA Devices Moderate Mar 3, 2021
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and b…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 3, 2021
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blade…
DeRoyal Industries Inc
FDA Devices Moderate Mar 3, 2021
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparosco…
Covidien Llc
FDA Devices Critical Feb 24, 2021
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed…
Combat Medical Systems, LLC
FDA Devices Moderate Feb 24, 2021
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical…
Getinge Group Logistics America, LLC
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis tr…
Baxter Healthcare Corporation
FDA Devices Moderate Feb 24, 2021
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplie…
Sky Medical Supplies and Equipments LLC
FDA Devices Critical Feb 24, 2021
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the item…
Combat Medical Systems, LLC
FDA Devices Moderate Feb 24, 2021
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
GE Healthcare, LLC
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis tr…
Baxter Healthcare Corporation
FDA Devices Moderate Feb 24, 2021
IOLMaster 700
Carl Zeiss Meditec AG
FDA Devices Moderate Feb 24, 2021
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA N…
Medtronic Neurosurgery
FDA Devices Moderate Feb 24, 2021
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011…
Medtronic Neurosurgery
FDA Devices Moderate Feb 24, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Cata…
LumiraDx
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dia…
Baxter Healthcare Corporation
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemo…
Baxter Healthcare Corporation
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single us…
Baxter Healthcare Corporation
FDA Devices Moderate Feb 24, 2021
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxi…
SenTec AG
FDA Devices Moderate Feb 24, 2021
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 …
Medtronic Neurosurgery
FDA Devices Moderate Feb 24, 2021
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Pho…
Baxter Healthcare Corporation
FDA Devices Critical Feb 24, 2021
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everythi…
Combat Medical Systems, LLC
CPSC Moderate Feb 24, 2021
Potter Electric Recalls Addressable Pull Stations Single/Dual Action Due to Failure to Alert to Fire
Potter Electric Signal Company, LLC, of St. Louis, Mo.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esopha…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protec…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 17, 2021
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pa…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier pro…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA,…
Prytime Medical Devices, Inc.
FDA Devices Moderate Feb 17, 2021
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory …
Aomori Olympus Co., Ltd.
FDA Devices Moderate Feb 17, 2021
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
Aomori Olympus Co., Ltd.