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 7921–7940 of 38,428 recalls

May 25, 2023· TELEFLEX LLC

Recalled Item: RUSCHELIT Safety Clear Tracheal Tube

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Preformed AGT Oral Endotracheal Tube Murphy Eye

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Endotracheal Tube oral/nasal Murphy Eye

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Slick Set Cuffed Endotracheal Tube and Stylet Set

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Preformed AGT Oral Endotracheal Tube Murphy Eye

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Preformed AGT Oral Endotracheal Tube Murphy Eye

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 25, 2023· TELEFLEX LLC

Recalled Item: Slick Set Uncuffed Endotracheal Tube and Stylet Set

The Issue: Reports of disconnection of the 15mm connector from

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

Class I — Serious Health HazardOngoing
May 24, 2023· Phadia Ab

Recalled Item: EliA GBM Wells

The Issue: Complaints that specific samples produced false positive EliA

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

Class II — Potential Health HazardOngoing
May 24, 2023· NeuMoDx Molecular Inc

Recalled Item: NeuMoDx Cartridge-used for extraction

The Issue: Top label on some of the NeuMoDx cartridges

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

Class II — Potential Health HazardOngoing
May 24, 2023· Cytocell Ltd.

Recalled Item: RET Distal Probe. Used in Fluorescence in situ hybridization (FISH)

The Issue: DNAs used during the manufacture of two affected

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

Class II — Potential Health HazardOngoing
May 24, 2023· Cytocell Ltd.

Recalled Item: RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH)

The Issue: DNAs used during the manufacture of two affected

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

Class II — Potential Health HazardOngoing
May 24, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: Power-PRO 2- A powered ambulance cot that consists of a platform

The Issue: Base leg assembly may bend and result in

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

Class II — Potential Health HazardOngoing
May 23, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed

The Issue: The kits incorrectly contain CirClamp subassembly 345CRSAK which

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: PriMatrix Ag Meshed

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: SurgiMend PRS Meshed

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: SurgiMend 3.0

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: SurgiMend 1.0

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: PriMatrix Fenestrated

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: PriMatrix Ag

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing
May 23, 2023· TEI Biosciences, Inc.

Recalled Item: PriMatrix

The Issue: out of specification endotoxin test results due

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

Class II — Potential Health HazardOngoing