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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 4981–5000 of 39,430 recalls

Class IIOngoing

Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18

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 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 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 · Device
View details →
Class IIOngoing

Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06

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 ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15

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

Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05

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 TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29

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

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

Remel, Inc

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.

September 20, 2024 · DeviceView details →
Class IIOngoing

Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01

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 KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06

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 LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03

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 BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06

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 PACK, MINOR - Medical convenience kits Model Number: VMED018-02

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 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 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 EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03

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 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 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 TRAY - Medical convenience kits Model Number: VMPB0003-10

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 SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15

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 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 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 KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16

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 AORTA PACK - Medical convenience kits Model Number: ESJH004-02

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 →
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