Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Specific lots of reprocessed electrophysiology catheters may contain...

Date: July 14, 2025
Company: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.

Affected Products

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH

Quantity: 398 units

Why Was This Recalled?

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report