Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 5,601–5,650 of 8,689
- Class II
Medical Device Recall · September 20, 2024
Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervousIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervousIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class I
Medical Device Recall · September 20, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard ENT - Medical convenience kits Model Number: VMED011-01Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nerIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervoIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervousIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 20, 2024
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Class II
Medical Device Recall · September 20, 2024
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous syIdentified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Class II
Medical Device Recall · September 19, 2024
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system includingMislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
- Class II
Medical Device Recall · September 19, 2024
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.