Z-2460-2025Class I

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

Name: Z-2460-2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-07-14
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-07-14 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH... on 2025-07-14. FDA classified it as Class I and gives the reason as "Specific lots of reprocessed electrophysiology catheters may contain small residual particulates". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2460-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-14
Posted: 2025-08-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall notification letter dated 7/14/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product immediately. 2. Please complete and return the enclosed response form via email to: [email protected] or fax: 866-767-1290, listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Upon receipt of your submitted response form, return labels and RGA information will be provided, if applicable. Your account will receive credit when the returned product is received. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request your customers return any affected product to you for collection and return to Medline Industries, LP. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 398 units
Distribution: US Nationwide.
Product codes and lots: 1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118; 18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP250106; 19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP241118; 20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP250106; 21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case), Lot Number: EP241118; 22) 401434RH, UDI-DI: 10197344043477(each), 10197344043477(case), Lot Number: EP241118; 23) 401435RH, UDI-DI: 10197344043460(each), 10197344043460(case), Lot Number: EP241118; 24) 401436RH, UDI-DI: 10197344043453(each), 10197344043453(case), Lot Number: EP250106; 25) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP241118; 26) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP250106; 27) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP241118; 28) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP250106; 29) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP241118; 30) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP250106; 31) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP241118; 32) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP250106; 33) 401448RH, UDI-DI: 10197344044283(each), 10197344044283(case), Lot Number: EP250106; 34) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP241118; 35) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP250106; 36) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP241118; 37) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP250106; 38) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP241118; 39) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP250106; 40) 401453RH, UDI-DI: 10197344044320(each), 10197344044320(case), Lot Number: EP250106; 41) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP241118; 42) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP250106; 43) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP241118; 44) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP250106; 45) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP241118; 46) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP250106; 47) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP241118; 48) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP250106; 49) 401877RH, UDI-DI: 10197344044436(each), 10197344044436(case), Lot Number: EP241118; 50) 401878RH, UDI-DI: 10197344044443(each), 10197344044443(case), Lot Number: EP241118; 51) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP241118; 52) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP250106; 53) 401891RH, UDI-DI: 10197344044467(each), 10197344044467(case), Lot Number: EP241118; 54) 401966RH, UDI-DI: 10197344044498(each), 10197344044498(case), Lot Number: EP250106; 55) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP241118; 56) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP250106; 57) 402008RH, UDI-DI: 10197344044573(each), 10197344044573(case), Lot Number: EP241118; 58) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP241118; 59) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP250106; 60) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP241118; 61) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP250106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2460-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2460-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-28

Product code NLH

K241156Class IIMedline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service and Savings, Inc. / cleared 2024-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)