MEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophy…
Reason for recall
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 / code information
- UDI
- 10197344043736(each), 10197344043736(case)
- Lot #
- EP250106; 2) 401222RH
- UDI
- 10197344043712(each), 10197344043712(case)
- Lot #
- EP241118; 3) 401222RH
- UDI
- 10197344043712(each), 10197344043712(case)
- Lot #
- EP250106; 4) 401223RH
- UDI
- 10197344043705(each), 10197344043705(case)
- Lot #
- EP250106; 5) 401226RH
- UDI
- 10197344043699(each), 10197344043699(case)
- Lot #
- EP241118; 6) 401226RH
- UDI
- 10197344043699(each), 10197344043699(case)
- Lot #
- EP250106; 7) 401227RH
- UDI
- 10197344043682(each), 10197344043682(case)
- Lot #
- EP250106; 8) 401260RH
- UDI
- 10197344043668(each), 10197344043668(case)
- Lot #
- EP241118; 9) 401260RH
- UDI
- 10197344043668(each), 10197344043668(case)
- Lot #
- EP250106; 10) 401261RH
- UDI
- 10197344043651(each), 10197344043651(case)
- Lot #
- EP250106; 11) 401305RH
- UDI
- 10197344043637(each), 10197344043637(case)
- Lot #
- EP250106; 12) 401309RH
- UDI
- 10197344043613(each), 10197344043613(case)
- Lot #
- EP250106; 13) 401353RH
- UDI
- 10197344043569(each), 10197344043569(case)
- Lot #
- EP241118; 14) 401353RH
- UDI
- 10197344043569(each), 10197344043569(case)
- Lot #
- EP250106; 15) 401381RH
- UDI
- 10197344043545(each), 10197344043545(case)
- Lot #
- EP241118; 16) 401381RH
- UDI
- 10197344043545(each), 10197344043545(case)
- Lot #
- EP250106; 17) 401399RH
- UDI
- 10197344043521(each), 10197344043521(case)
- Lot #
- EP241118; 18) 401399RH
- UDI
- 10197344043521(each), 10197344043521(case)
- Lot #
- EP250106; 19) 401430RH
- UDI
- 10197344043491(each), 10197344043491(case)
- Lot #
- EP241118; 20) 401430RH
- UDI
- 10197344043491(each), 10197344043491(case)
- Lot #
- EP250106; 21) 401433RH
- UDI
- 10197344043484(each), 10197344043484(case)
- Lot #
- EP241118; 22) 401434RH
- UDI
- 10197344043477(each), 10197344043477(case)
- Lot #
- EP241118; 23) 401435RH
- UDI
- 10197344043460(each), 10197344043460(case)
- Lot #
- EP241118; 24) 401436RH
- UDI
- 10197344043453(each), 10197344043453(case)
- Lot #
- EP250106; 25) 401441RH
- UDI
- 10197344043439(each), 10197344043439(case)
- Lot #
- EP241118; 26) 401441RH
- UDI
- 10197344043439(each), 10197344043439(case)
- Lot #
- EP250106; 27) 401442RH
- UDI
- 10197344044245(each), 10197344044245(case)
- Lot #
- EP241118; 28) 401442RH
- UDI
- 10197344044245(each), 10197344044245(case)
- Lot #
- EP250106; 29) 401443RH
- UDI
- 10197344044252(each), 10197344044252(case)
- Lot #
- EP241118; 30) 401443RH
- UDI
- 10197344044252(each), 10197344044252(case)
- Lot #
- EP250106; 31) 401444RH
- UDI
- 10197344044269(each), 10197344044269(case)
- Lot #
- EP241118; 32) 401444RH
- UDI
- 10197344044269(each), 10197344044269(case)
- Lot #
- EP250106; 33) 401448RH
- UDI
- 10197344044283(each), 10197344044283(case)
- Lot #
- EP250106; 34) 401449RH
- UDI
- 10197344044290(each), 10197344044290(case)
- Lot #
- EP241118; 35) 401449RH
- UDI
- 10197344044290(each), 10197344044290(case)
- Lot #
- EP250106; 36) 401450RH
- UDI
- 10197344044306(each), 10197344044306(case)
- Lot #
- EP241118; 37) 401450RH
- UDI
- 10197344044306(each), 10197344044306(case)
- Lot #
- EP250106; 38) 401451RH
- UDI
- 10197344044313(each), 10197344044313(case)
- Lot #
- EP241118; 39) 401451RH
- UDI
- 10197344044313(each), 10197344044313(case)
- Lot #
- EP250106; 40) 401453RH
- UDI
- 10197344044320(each), 10197344044320(case)
- Lot #
- EP250106; 41) 401474RH
- UDI
- 10197344044351(each), 10197344044351(case)
- Lot #
- EP241118; 42) 401474RH
- UDI
- 10197344044351(each), 10197344044351(case)
- Lot #
- EP250106; 43) 401860RH
- UDI
- 10197344044382(each), 10197344044382(case)
- Lot #
- EP241118; 44) 401860RH
- UDI
- 10197344044382(each), 10197344044382(case)
- Lot #
- EP250106; 45) 401863RH
- UDI
- 10197344044399(each), 10197344044399(case)
- Lot #
- EP241118; 46) 401863RH
- UDI
- 10197344044399(each), 10197344044399(case)
- Lot #
- EP250106; 47) 401864RH
- UDI
- 10197344044405(each), 10197344044405(case)
- Lot #
- EP241118; 48) 401864RH
- UDI
- 10197344044405(each), 10197344044405(case)
- Lot #
- EP250106; 49) 401877RH
- UDI
- 10197344044436(each), 10197344044436(case)
- Lot #
- EP241118; 50) 401878RH
- UDI
- 10197344044443(each), 10197344044443(case)
- Lot #
- EP241118; 51) 401890RH
- UDI
- 10197344044450(each), 10197344044450(case)
- Lot #
- EP241118; 52) 401890RH
- UDI
- 10197344044450(each), 10197344044450(case)
- Lot #
- EP250106; 53) 401891RH
- UDI
- 10197344044467(each), 10197344044467(case)
- Lot #
- EP241118; 54) 401966RH
- UDI
- 10197344044498(each), 10197344044498(case)
- Lot #
- EP250106; 55) 402004RH
- UDI
- 10197344044566(each), 10197344044566(case)
- Lot #
- EP241118; 56) 402004RH
- UDI
- 10197344044566(each), 10197344044566(case)
- Lot #
- EP250106; 57) 402008RH
- UDI
- 10197344044573(each), 10197344044573(case)
- Lot #
- EP241118; 58) 402010RH
- UDI
- 10197344044597(each), 10197344044597(case)
- Lot #
- EP241118; 59) 402010RH
- UDI
- 10197344044597(each), 10197344044597(case)
- Lot #
- EP250106; 60) 402012RH
- UDI
- 10197344043835(each), 10197344043835(case)
- Lot #
- EP241118; 61) 402012RH
- UDI
- 10197344043835(each), 10197344043835(case)
- Lot #
- EP250106
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What the firm is doing
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: recalls@medline.com 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 recalls@medline.com.
DistributionShow detailsHide
US Nationwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2460-2025
- FDA 510(k) clearance · K241156The device's official FDA premarket clearance record
- FDA device classification · NLHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1220The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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