Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO
Reason for recall
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
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.
Affected products & lots
- MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKUDYNJ63789AAffected lot24JBM406
- 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKUDYNJ17321GAffected lot22HBF916
- 3) D&C/CYSTO, Medline Kit Number/SKUDYNJ909989BAffected lot25EBC752
- 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53214Affected lot21HMC179
- 5) DIAGNOSTIC LAPAROSCOPY, Medline Kit Number/SKUDYNJ903390KAffected lot25JBB643
- 6) GENERAL LAPAROSCOPY, Medline Kit Number/SKUDYNJ902700CAffected lot21EBL762
- 7) GENERAL LAPAROSCOPY, Medline Kit Number/SKUDYNJ902700DAffected lot21IBA023
- 8) GENERAL LAPAROSCOPY, Medline Kit Number/SKUDYNJ902700FAffected lot23LBL539
- 9) GENERAL-CVOR MINOR, Medline Kit Number/SKUDYNJ64324AAffected lot24BBQ307
- 10) GYN LAP, Medline Kit Number/SKUDYNJT7061Affected lot25LBJ399
- 11) GYN LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53631FAffected lot21BBM589
- 12) GYN MINOR PACK, Medline Kit Number/SKUDYNJ85910Affected lot24BMD100
- 13) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKUDYKMBNDL117AAffected lot22BLB033
- 14) LAP, Medline Kit Number/SKUDYNJ904585BAffected lot21BBA929
- 15) LAP, Medline Kit Number/SKUDYNJ904585CAffected lot22FBA957
- 16) LAP CHOLE CDS, Medline Kit Number/SKUCDS983255RAffected lot22DMB055
- 17) LAP CHOLE CDS, Medline Kit Number/SKUCDS983255SAffected lot24HMF023
- 18) LAP CHOLE CDS, Medline Kit Number/SKUCDS983255TAffected lot25HMH537
- 19) LAPAROSCOPY, Medline Kit Number/SKUDYNJ89908Affected lot25DBC466
- 20) LAPAROSCOPY, Medline Kit Number/SKUDYNJ910517Affected lot24FBH143
- 21) LAPAROSCOPY, Medline Kit Number/SKUDYNJ910517AAffected lot25ABS355
- 22) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ06958IAffected lot21EBC527
- 23) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ06958JAffected lot25ABW220
- 24) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53992CAffected lot21BBM609
- 25) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53992DAffected lot21GBJ693
- 26) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53992FAffected lot23AMB100
- 27) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53992GAffected lot23LMB368
- 28) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ53992IAffected lot25JMF523
- 29) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ67160Affected lot21IBQ873
- 30) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ84211Affected lot23DMF493
- 31) LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJHS0235CAffected lot21AME355
- 32) LAPAROSCOPY PACK VICTORY, Medline Kit Number/SKUDYNJ81148Affected lot22FBV834
- 33) LAPAROSCOPY PK, Medline Kit Number/SKUDYNJ14073BAffected lot21VBC669
- 34) LAPAROSCOPY PK, Medline Kit Number/SKUDYNJ61404AAffected lot21KBG020
- 35) LAPAROSCOPY PK, Medline Kit Number/SKUDYNJ61404BAffected lot24IBG915
- 36) LAPAROSCOPY PK, Medline Kit Number/SKUDYNJ61404CAffected lot25IBL608
- 37) LAPAROSCOPY PK, Medline Kit Number/SKUDYNJ61404DAffected lot26ABQ031
- 38) LAPAROSCOPY/GYN PACK, Medline Kit Number/SKUDYNJ0384702UAffected lot24KMB187
- 39) PACK LAPAROSCOPY, Medline Kit Number/SKUDYNJ0553254OAffected lot21AMA546
- 40) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKUDYNJ908046AAffected lot22FDB153
- 41) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKUDYNJ908046BAffected lot22IDA125
- 42) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKUDYNJ908046CAffected lot23ADB627
- 43) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKUDYNJ908046DAffected lot23HDA536
- 44) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKUDYNJ908046FAffected lot25DMC199
- 45) PROLAPSE PACK, Medline Kit Number/SKUDYNJ85390Affected lot23KBM872
- 46) RICH CYSTO, Medline Kit Number/SKUDYNJ902183IAffected lot23GBI795
- 47) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKUDYNJ66263BAffected lot23BBS137
- 48) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKUDYNJ66263CAffected lot24EBB572
- 49) SMJ LAPAROSCOPY PACK, Medline Kit Number/SKUDYNJ25763JAffected lot21DMA464
- 50) WCH GENERAL LAPAROSCOPY, Medline Kit Number/SKUDYNJ902700GAffected lot24HBL056
What the firm is doing
Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2493-2026
- FDA device classification · FDEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch 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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