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 2681–2700 of 38,428 recalls

February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 9 Coated Regular and 9 Nude Regular Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 18 Coated Super and 18 Nude Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 3 Month Heavy Flow Bundle

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 36 Coated Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: Initiation 3 Month Heavy Flow Bundle

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 18 Coated Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: Regular Flow Bundle

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 36 Coated Regular Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 3 Month Trial Tampon Box

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: Initiation 18 Coated Super and 18 Nude Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: All in One Bundle

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 9 Coated Regular and 9 Coated Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 9 Coated Regular Tampons and 9 Nude Regular Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· DAYE (ANNE'S DAY LTD)

Recalled Item: 18 Coated Regular and 18 Coated Super Tampons

The Issue: Product lacks 510(k) clearance

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing
February 17, 2025· Oridion Medical 1987 Ltd.

Recalled Item: Microstream Instructions for Use and Part Number used with - Product Description

The Issue: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Na

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

Class II — Potential Health HazardOngoing