CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Medline procedure kits labeled as: Angio Drape Pack recalled
Medline Industries LP - Northfield is recalling Medline procedure kits labeled as: Angio Drape Pack (Drlul)-LF, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1437-2025
- FDA event ID
- 96374
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2025
- FDA classified
- 25 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 11 Feb 2025 | Recall initiated by company | |
| 25 Mar 2025 | Classified by FDA | +42 days |
| 2 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A; 6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N; 7) ARTERIOGRAM PACK, Pack Number DYNJ34442F; 8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I; 9) CARDIAC CATH PACK, Pack Number DYNJ31733C; 10) CARDIAC CATH PACK, Pack Number DYNJ41315A; 11) CARDIAC CATH PACK-LF, Pack Number DYNJ0380198L; 12) CATH LAB PACK, Pack Number 0M-CP31796Q; 13) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 14) CATH LAB TRAY, Pack Number 00-401610J; 15) CHRISTUS SR CATH LAB PACK, Pack Number DYNJ60931C; 16) CRMC CATH LAB TRAY JUDKINS-LF, Pack Number DYNJ61088F; 17) CRMC NEURO ENDO HYBRID-LF, Pack Number DYNJ61101D; 18) EP PACK MORNINGSIDE, Pack Number DYNJ69301; 19) FEMORAL TRAY 2, Pack Number DYNJ68812C; 20) INTERVENTIONAL MINOR PACK, Pack Number DYNJ24615D; 21) INTERVENTIONAL PACK, Pack Number DYNJ54253; 22) INTERVENTIONAL RADIOLOGY PK-LF, Pack Number PHS605358025B; 23) MORNINGSIDE CARDIAC CATH, Pack Number DYNJ58339A; 24) OR INTERVENTIONAL PACK, Pack Number DYNJ46934A; 25) PACK,CARDIAC CATH, Pack Number DYNJ65481; 26) PK, RADIOLOGY-SPECIALS, Pack Number DYNJ59628C; 27) PTCA TRAY-LF, Pack Number DYNJ07252V; 28) RADIOLOGY PACK, Pack Number DYNJ45393A; 29) RR-ANGIOGRAPHY DRAPE PACK-LF, Pack Number DYNJ0608549M; 30) SPEC ANGIO PACK (SASJK)642-LF, Pack Number DYNJ47586F; 31) SPECIALS LINE PACK, Pack Number DYNJ69504; 32) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 33) TV-CARDIAC CATH PACK-LF, Pack Number DYNJ41564P; 34) UTHET TYLER ELECTROPHYSIOLOGY, Pack Number DYNJ68672C
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Which lots are affected?
1) Pack Number DYNJ47718D: UDI/DI 10195327528331 (each) 40195327528332 (case), Lot Number 23LME887A; 2) Pack Number DYNJ69678: UDI/DI 10193489968156 (each) 40193489968157 (case), Lot Number 23EMD520A; 3) Pack Number DYNJ64936A: UDI/DI 10193489978759 (each) 40193489978750 (case), Lot Number 21LBW389A; 4) Pack Number DYNJ49621C: UDI/DI 10195327008581 (each) 40195327008582 (case), Lot Number 23LMG954A; 5) Pack Number DYNJ61266A: UDI/DI 10195327057763 (each) 40195327057764 (case), Lot Number 23GBF536A; 6) Pack Number DYNJ35916N: UDI/DI 10195327223977 (each) 40195327223978 (case), Lot Number 23EBE626A; 7) Pack Number DYNJ34442F: UDI/DI 10193489881424 (each) 40193489881425 (case), Lot Number 23LMG342A; 8) Pack Number DYNJ53588I: UDI/DI 10195327014001 (each) 40195327014002 (case), Lot Number 23EME005A; 9) Pack Number DYNJ31733C: UDI/DI 10889942875290 (each) 40889942875291 (case), Lot Number 21BBG459B; 10) Pack Number DYNJ41315A: UDI/DI 10888277907089 (each) 40888277907080 (case), Lot Number 22LBA182A; 11) Pack Number DYNJ0380198L: UDI/DI 10193489916478 (each) 40193489916479 (case), Lot Number 22GBH915A; 12) Pack Number 0M-CP31796Q: UDI/DI 10889942756483 (each) 40889942756484 (case), Lot Number 21HBP168A; 13) Pack Number DYNJ0194968AG: UDI/DI 10195327179557 (each) 40195327179558 (case), Lot Number 24AME980A; 14) Pack Number 00-401610J: UDI/DI 10889942731640 (each) 40889942731641 (case), Lot Number 23LBL085Z; 15) Pack Number DYNJ60931C: UDI/DI 10193489952940 (each) 40193489952941 (case), Lot Number 21JMI207A; 16) Pack Number DYNJ61088F: UDI/DI 10195327451585 (each) 40195327451586 (case), Lot Number 23LMG703A; 17) Pack Number DYNJ61101D: UDI/DI 10195327451813 (each) 40195327451814 (case), Lot Number 23HME348A; 18) Pack Number DYNJ69301: UDI/DI 10193489926101 (each) 40193489926102 (case), Lot Number 23CBL353A; 19) Pack Number DYNJ68812C: UDI/DI 10195327449452 (each) 40195327449453 (case), Lot Number 23KMC169A; 20) Pack Number DYNJ24615D: UDI/DI 10889942436057 (each) 40889942436058 (case), Lot Number 21JMF491A; 21) Pack Number DYNJ54253: UDI/DI 10889942474509 (each) 40889942474500 (case), Lot Number 20KBM762A; 22) Pack Number PHS605358025B: UDI/DI 10193489498998 (each) 40193489498999 (case), Lot Number 23FMD837A; 23) Pack Number DYNJ58339A: UDI/DI 10193489483147 (each) 40193489483148 (case), Lot Number 21EBP494A; 24) Pack Number DYNJ46934A: UDI/DI 10888277856998 (each) 40888277856999 (case), Lot Number 23BBR783A; 25) Pack Number DYNJ65481: UDI/DI 10193489280463 (each) 40193489280464 (case), Lot Number 23IMG363A; 26) Pack Number DYNJ59628C: UDI/DI 10193489813128 (each) 40193489813129 (case), Lot Number 23LBK499A; 27) Pack Number DYNJ07252V: UDI/DI 10193489744644 (each) 40193489744645 (case), Lot Number 22HBO256A; 28) Pack Number DYNJ45393A: UDI/DI 10889942188765 (each) 40889942188766 (case), Lot Number 20FMA718A; 29) Pack Number DYNJ0608549M: UDI/DI 10195327477387 (each) 40195327477388 (case), Lot Number 23LMD710A; 30) Pack Number DYNJ47586F: UDI/DI 10195327400156 (each) 40195327400157 (case), Lot Number 23LME689A; 31) Pack Number DYNJ69504: UDI/DI 10193489950243 (each) 40193489950244 (case), Lot Number 24ABA461Z; 32) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMB245A; 33) Pack Number DYNJ41564P: UDI/DI 10195327177423 (each) 40195327177424 (case), Lot Number 23HMC543A; 34) Pack Number DYNJ68672C: UDI/DI 10195327191566 (each) 40195327191567 (case), Lot Number 23BBR790A
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 96374This product is part of a recall event; the main page for the event is Medline procedure kits labeled as: C Scope Disposable Kit recalled.
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