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 17401–17420 of 38,428 recalls

June 27, 2019· Medtronic MiniMed

Recalled Item: MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: MiniMed Paradigm Model 511 Insulin Pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Veo Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medtronic MiniMed

Recalled Item: Medtronic MiniMed Paradigm Insulin pump

The Issue: The action is being initiated due to potential

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

Class II — Potential Health HazardOngoing
June 27, 2019· Medicrea International

Recalled Item: Medicrea Pass LP

The Issue: It has been determined that some Pedicle system

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products Sodium Hypochlorite - 6%

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products Sodium Hypochlorite - 3%

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products 3% Sodium Hypochlorite

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products Sodium Hypochlorite - 6%

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products CanalClean Endodontic Irrigation Kit

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Inter-Med Llc

Recalled Item: Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes

The Issue: The affected lots may be packaged in syringes

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

Class II — Potential Health HazardTerminated
June 27, 2019· Angiodynamics, Inc.

Recalled Item: AngioDynamics VenaCure EVLT NeverTouch Procedure Kit

The Issue: The affected product is properly labelled with an

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

Class II — Potential Health HazardTerminated
June 27, 2019· Baxter Healthcare Corporation

Recalled Item: EXACTAMED Oral Dispensers

The Issue: EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may

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

Class III — Low RiskTerminated
June 27, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: N Cuvette Segments for BN ProSpec System-IVD a system for

The Issue: Iincreased (falsely elevated) Albumin results compared to expected

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

Class II — Potential Health HazardTerminated