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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 4941–4960 of 39,430 recalls

Class IIOngoing

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Onkos Surgical, Inc.

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

September 22, 2024 · DeviceView details →
Class IIOngoing

Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06

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

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 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 PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

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 IOngoing

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Maquet Cardiovascular, LLC

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03

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 D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02

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 KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07

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 PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

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 KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05

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 CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07

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 OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15

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 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 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 OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

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 MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03

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 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 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 UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02

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 CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

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

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 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 TOTAL KNEE - Medical convenience kits Model Number: GRND008-09

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 →
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