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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 5021–5040 of 39,430 recalls

Class IIOngoing

SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. 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 MINOR PACK - Medical convenience kits Model Number: MMOK013-03

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 · Device
View details →
Class IIOngoing

Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02

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 1/2X3 Model/Catalog Number: 801407. 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 INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01

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

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 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 EP TRAY - Medical convenience kits Model Number: VAST038-04

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 SPECIALS PACK - Medical convenience kits Model Number: VAST031-08

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

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06

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 LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18

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

Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06

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 SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

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 C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34

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 HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03

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 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 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 GYN PAC - Medical convenience kits Model Number: SJGY20-02

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 LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25

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 EP PACK - Medical convenience kits Model Number: VANW018-06

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

Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083

Baxter Healthcare Corporation

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

September 19, 2024 · DeviceView details →
Class IIOngoing

Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)

Covidien LP

Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

September 19, 2024 · DeviceView details →
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