Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 5,551–5,600 of 8,689
- Class II
Medical Device Recall · September 20, 2024
SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sysIdentified 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 1X1 Model/Catalog Number: 801403. 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 CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02Sponge 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 SPECIALS PACK - Medical convenience kits Model Number: VAST031-08Sponge 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 EP PACK - Medical convenience kits Model Number: VANW018-06Sponge 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 LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18Sponge 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
- Class II
Medical Device Recall · September 20, 2024
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10Sponge 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 IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08Sponge 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
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. 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
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sysIdentified 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 IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01Sponge 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 INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03Sponge 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 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 HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03Sponge 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 EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19Sponge 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 GYN PAC - Medical convenience kits Model Number: SJGY20-02Sponge 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 POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19Sponge 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 1/2X1/2 Model/Catalog Number: 801400. 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 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 SHOULDER PACK - Medical convenience kits Model Number: PANJ005Sponge 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 ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02Sponge 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 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systIdentified 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 ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06Sponge 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 STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systemIdentified 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 PACK - Medical convenience kits Model Number: MAMC218-18Sponge 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 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systemIdentified 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 DRAPE - Medical convenience kits Model Number: VAST020-06Sponge 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 PACK - Medical convenience kits Model Number: WRNM047-05Sponge 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 TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29Sponge 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
- 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
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 ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01Sponge 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 LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03Sponge 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 BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06Sponge 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 PACK, MINOR - Medical convenience kits Model Number: VMED018-02Sponge 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 1/4X3 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
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03Sponge 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 STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous sysIdentified 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 SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15Sponge 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 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
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10Sponge 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 C SECTION PACK - Medical convenience kits Model Number: SJCS66-02Sponge 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 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
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous systIdentified 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
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture strinIdentified 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 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 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 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