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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5001–5020 of 39,430 recalls

Class IIOngoing

Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

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 system, during surgery.

Integra LifeSciences Corp.

Identified 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ENT - Medical convenience kits Model Number: VMED011-01

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

AVID Medical, Inc.

Sponge 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

September 20, 2024 · DeviceView details →
Class IIOngoing

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 string attached for ease in performing postsurgical count verification. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

Integra LifeSciences Corp.

Identified 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

September 20, 2024 · DeviceView details →
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