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 35981–36000 of 38,428 recalls

March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: Vented Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip.

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Stryker Endoscopy

Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip

The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in

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

Class II — Potential Health HazardTerminated
March 27, 2013· Accuray Incorporated

Recalled Item: RoboCouch Patient Positioning System Product Usage: is intended for use

The Issue: A5 gearboxes responsible for pitch (head up and

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

Class II — Potential Health HazardTerminated