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 32161–32180 of 38,428 recalls

October 6, 2014· Microbiologics Inc

Recalled Item: KWIK-STIK

The Issue: This strain should be resistant to high levels

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

Class II — Potential Health HazardTerminated
October 6, 2014· Microbiologics Inc

Recalled Item: KWIK-STIK

The Issue: This strain should be resistant to high levels

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

Class II — Potential Health HazardTerminated
October 6, 2014· Microbiologics Inc

Recalled Item: LYFO-DISK

The Issue: This strain should be resistant to high levels

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

Class II — Potential Health HazardTerminated
October 6, 2014· Alliance Tech Medical, Inc

Recalled Item: Alliance Tech Medical

The Issue: Patients have experienced a bad taste associated with

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

Class II — Potential Health HazardCompleted
October 6, 2014· Alcon Research, Ltd.

Recalled Item: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716

The Issue: The recalling firm received complaints related to leakage

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage:

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage:

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· MWT Materials, Inc.

Recalled Item: Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and

The Issue: When not used correctly, Accusorb MRI products may

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

Class II — Potential Health HazardTerminated
October 6, 2014· Baxter Healthcare Corp.

Recalled Item: HomeChoice Automated PD system and HomeChoice Pro Automated PD system

The Issue: There are additional and updated warning and cautions

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

Class II — Potential Health HazardTerminated
October 6, 2014· PEROUSE MEDICAL

Recalled Item: Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended

The Issue: Additional instructions for use due to inability to

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

Class II — Potential Health HazardTerminated
October 6, 2014· PEROUSE MEDICAL

Recalled Item: Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used

The Issue: Additional instructions for use due to inability to

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

Class II — Potential Health HazardTerminated
October 6, 2014· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: DPM 6 Patient Monitor and DPM 7 Patient Monitor. The

The Issue: Mindray has identified an issue that involves the

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

Class II — Potential Health HazardTerminated