Reported Sep 3, 2025 · Ongoing

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models…

MEDLINE INDUSTRIES, LP - Northfield

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

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

Lot codes and dates: 61 of 61 products
Products covered by this recall
# Barcodes Product as published
1 1019734404371210197344043712 Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case)
2 1019734404371210197344043712 Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case)
3 1019734404370510197344043705 Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case)
4 1019734404369910197344043699 Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case)
5 1019734404369910197344043699 Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case)
6 1019734404368210197344043682 Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case)
7 1019734404366810197344043668 Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case)
8 1019734404366810197344043668 Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case)
9 1019734404365110197344043651 Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case)
10 1019734404363710197344043637 Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case)
11 1019734404361310197344043613 Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case)
12 1019734404356910197344043569 Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case)
13 1019734404356910197344043569 Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case)
14 1019734404354510197344043545 Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case)
15 1019734404354510197344043545 Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case)
16 1019734404352110197344043521 Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case)
17 1019734404352110197344043521 Lot Number: EP241118; 18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case)
18 1019734404349110197344043491 Lot Number: EP250106; 19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case)
19 1019734404349110197344043491 Lot Number: EP241118; 20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case)
20 1019734404348410197344043484 Lot Number: EP250106; 21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case)
Page 1 of 4
Amount recalled: 398 units

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Medical device recalls

Other recalls from MEDLINE INDUSTRIES, LP - Northfield

80 in total.

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#	Barcodes	Product as published
1	`1019734404371210197344043712`	Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case)
2	`1019734404371210197344043712`	Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case)
3	`1019734404370510197344043705`	Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case)
4	`1019734404369910197344043699`	Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case)
5	`1019734404369910197344043699`	Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case)
6	`1019734404368210197344043682`	Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case)
7	`1019734404366810197344043668`	Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case)
8	`1019734404366810197344043668`	Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case)
9	`1019734404365110197344043651`	Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case)
10	`1019734404363710197344043637`	Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case)
11	`1019734404361310197344043613`	Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case)
12	`1019734404356910197344043569`	Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case)
13	`1019734404356910197344043569`	Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case)
14	`1019734404354510197344043545`	Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case)
15	`1019734404354510197344043545`	Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case)
16	`1019734404352110197344043521`	Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case)
17	`1019734404352110197344043521`	Lot Number: EP241118; 18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case)
18	`1019734404349110197344043491`	Lot Number: EP250106; 19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case)
19	`1019734404349110197344043491`	Lot Number: EP241118; 20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case)
20	`1019734404348410197344043484`	Lot Number: EP250106; 21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case)