Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 4,851–4,900 of 7,979
- 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
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
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 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
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15Sponge 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 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 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 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
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 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 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 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 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 BIOPSY PACK - Medical convenience kits Model Number: VANW019-04Sponge 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 KIT, SPINE - Medical convenience kits Model Number: EUOR004-03Sponge 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 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
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
remel BactiDrop Acridine Orange, REF 21502, 50 per package.A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
- 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 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
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. 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 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 LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25Sponge 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
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 FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02Sponge 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, SPINE - Medical convenience kits Model Number: EUOR004-02Sponge 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
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 ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02Sponge 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
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 ORTHO PACK -Medical convenience kits Model Number: MMOK006-04Sponge 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
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 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 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 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 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 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 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 KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05Sponge 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 1/2X1-1/2 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 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 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
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 GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02Sponge 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
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 VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29Sponge 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