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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 4961–4980 of 39,430 recalls

Class IIOngoing

Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04

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 IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

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 1/2X1-1/2 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 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 CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02

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

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 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 VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29

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 IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08

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 IIOngoing

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 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

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 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

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 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 IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

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 INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03

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 EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

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 POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19

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

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 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 SHOULDER PACK - Medical convenience kits Model Number: PANJ005

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 ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

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

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 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 ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06

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 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 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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