Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 9041–9060 of 38,428 recalls

December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS...

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS...

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: a) MEDLINE HAND PACK

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY

The Issue: The recall is due to the perforated bag

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Zimmer, Inc.

Recalled Item: Identity Shoulder System Resection Planer 35mm Resection Planer

The Issue: Two planers were found to be unusable during

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: FUSION Dual Pump Packs

The Issue: Weld protrusion/physical gap between the housing and phaco

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: Veritas Advanced Infusion Packs

The Issue: Weld protrusion/physical gap between the housing and phaco

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: Single-Use Packs

The Issue: Weld protrusion/physical gap between the housing and phaco

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Mobius Imaging, LLC

Recalled Item: MobiCT-32 AIRO Mobile CT Scanner

The Issue: Stryker received one report of an injury to

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Philips Respironics, Inc.

Recalled Item: Philips Trilogy 100 Ventilator

The Issue: The replacement silicone sound abatement foam installed into

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
December 7, 2022· The Anspach Effort, Inc.

Recalled Item: Pediatric Craniotome

The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· The Anspach Effort, Inc.

Recalled Item: Adult Craniotome

The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· Siemens Healthcare Diagnostics, Inc.

Recalled Item: IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with

The Issue: for Functional Sensitivity to not meet Instructions

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2022· The Anspach Effort, Inc.

Recalled Item: 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿

The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing