Class II FDA device recall · Z-1437-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1437-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2025-02-11

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1437-2025 · Source: openFDA enforcement.