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 20081–20100 of 38,428 recalls

July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (INTL) M

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (INTL) N

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 M NICU (CPM)

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (INTL) N - ROHS

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20 (INTL) N

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (INTL) N W/PRINTER

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (US) M

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20 (US) N W/PRINTER

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (INTL) M W/PRINTER

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (US) M W/PRINTER

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Endologix

Recalled Item: ENDOLOGIX AFX Endovascular AAA System

The Issue: Endologix is notifying physicians of patient tailored surveillance

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

Class I — Serious Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 N CYVITAL

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (INTL) N

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (US) M TO MASIMO

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (INTL) M

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (INTL) N W/PRINTER

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: Capnostream20 (US) M W/PRINTER TO MASIMO

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (US) N W/PRINTER - ROHS

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated
July 31, 2018· Oridion Medical 1987 Ltd.

Recalled Item: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS

The Issue: The date/time, nurse call and alarm settings of

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

Class II — Potential Health HazardTerminated