Z-1446-2025Class II

Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack...

Name: Z-1446-2025 Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-11 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number... on 2025-02-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1446-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-11
Posted: 2025-03-25
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L
Product code: MLS Labor And Delivery Kit
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.
FDA root cause: Under Investigation by firm
Action: Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583
Quantity in commerce: 1958 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case), Lot Number 23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case), Lot Number 21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case), Lot Number 21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case), Lot Number 22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case), Lot Number 23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case), Lot Number 22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case), Lot Number 23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case), Lot Number 22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case), Lot Number 22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case), Lot Number 21EBN038A; 11) Pack Number DYNJ43395: UDI/DI 10888277049444 (each) 40888277049445 (case), Lot Number 21LMG173A; 12) Pack Number DYNJ0594115L: UDI/DI 10193489382730 (each) 40193489382731 (case), Lot Number 20JKB018A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1446-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1435-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1436-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1437-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1438-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1439-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1440-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1441-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1442-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1443-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1444-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1445-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1446-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1447-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1448-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1449-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1450-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1451-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1452-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25
Z-1453-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-25

Product code MLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)