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 2281–2300 of 38,428 recalls

April 22, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Plum Duo

The Issue: Internal testing found that Plum Duo pumps with

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

Class II — Potential Health HazardOngoing
April 22, 2025· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI

The Issue: Affected kits contain recalled Integra Lifesciences Codman Disposable

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

Class I — Serious Health HazardOngoing
April 22, 2025· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY

The Issue: Affected kits contain recalled Integra Lifesciences Codman Disposable

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

Class I — Serious Health HazardOngoing
April 22, 2025· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI

The Issue: Affected kits contain recalled Integra Lifesciences Codman Disposable

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

Class I — Serious Health HazardOngoing
April 22, 2025· C-RAD POSITIONING AB

Recalled Item: Catalyst+ Product Name: C4D software used in conjunction

The Issue: Software issue with scanning equipment that can results

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

Class II — Potential Health HazardOngoing
April 22, 2025· Ethicon Endo-Surgery Inc

Recalled Item: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm

The Issue: Firm has received an increase in reports regarding

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

Class I — Serious Health HazardOngoing
April 21, 2025· Capnia Inc

Recalled Item: Precision Sampling Set

The Issue: Sampling set nasal cannula used with End-Tidal Carbon

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

Class II — Potential Health HazardOngoing
April 21, 2025· American Contract Systems, Inc.

Recalled Item: LOWER EXTREMITY

The Issue: Test results for cast padding component included in

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

Class II — Potential Health HazardOngoing
April 21, 2025· Becton Dickinson Infusion Therapy Systems, Inc.

Recalled Item: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN

The Issue: Due to a manufacturing defect IV catheter may

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

Class II — Potential Health HazardOngoing
April 21, 2025· Numed Inc

Recalled Item: BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

The Issue: Balloon extension lumens are not printed correctly. Specifically,

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

Class II — Potential Health HazardTerminated
April 17, 2025· C.R. Bard Inc

Recalled Item: Bard¿ Single Intragastric Linton Balloon Tube

The Issue: Due to customer complaints, there is a potential

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

Class I — Serious Health HazardOngoing
April 17, 2025· Cook Incorporated

Recalled Item: Check=Flo Performer Introducer

The Issue: Cook Medical identified that devices from the affected

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

Class II — Potential Health HazardOngoing
April 17, 2025· Cook Incorporated

Recalled Item: Check=Flo Performer Introducer

The Issue: Cook Medical identified that devices from the affected

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

Class II — Potential Health HazardOngoing
April 17, 2025· C.R. Bard Inc

Recalled Item: Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)

The Issue: Due to customer complaints, there is a potential

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

Class I — Serious Health HazardOngoing
April 17, 2025· C.R. Bard Inc

Recalled Item: Bard¿ Blakemore Esophageal-Nasogastric Tube (Child)

The Issue: Due to customer complaints, there is a potential

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

Class I — Serious Health HazardOngoing
April 17, 2025· C.R. Bard Inc

Recalled Item: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube

The Issue: Due to customer complaints, there is a potential

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

Class I — Serious Health HazardOngoing
April 17, 2025· C.R. Bard Inc

Recalled Item: Bard Blakemore Esophageal-Nasogastric Tube (Adult)

The Issue: Due to customer complaints, there is a potential

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

Class I — Serious Health HazardOngoing
April 17, 2025· Cook Incorporated

Recalled Item: Tornado Embolization Microcoil

The Issue: Cook Medical identified that devices from the affected

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

Class II — Potential Health HazardOngoing
April 17, 2025· Straumann USA LLC

Recalled Item: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

The Issue: Incorrect blister labelling

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

Class II — Potential Health HazardOngoing
April 16, 2025· Luminex Corporation

Recalled Item: VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test

The Issue: It was determined that the consumable issue may

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

Class II — Potential Health HazardCompleted