Medline ReNewal Catheters (Medline) – Particulate Contamination (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
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
Products Sold
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
MEDLINE INDUSTRIES, LP Northfield is recalling Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Cathe due to Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026