Z-0160-2025Class II

Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS...

Name: Z-0160-2025 Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-09-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-09-04 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF... on 2024-09-04. FDA classified it as Class II and gives the reason as "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0160-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-04
Posted: 2024-10-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40836F; 7) ENT PACK, REF DYNJ44249J; 8) TONSIL PACK, REF DYNJ44349L; 9) TONSIL PACK, REF DYNJ44349M; 10) NASAL PACK, REF DYNJ53200C; 11) TONSIL & ADENOIDS PACK, REF DYNJ53270C; 12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A; 13) HEAD AND NECK PACK, REF DYNJ55255C; 14) ENT T&A PACK, REF DYNJ58979; 15) EENT PACK, REF DYNJ62927; 16) ENT, REF DYNJ63190A; 17) D L B PACK, REF DYNJ66274A; 18) ASC T&A, REF DYNJ67109B; 19) TONSIL T AND A PACK SHD, REF DYNJ68417C; 20) T A PACK, REF DYNJ80227B; 21) TONSIL AND ADENOID PACK, REF DYNJ80559A; 22) T AND A PACK UMMC KIT, REF DYNJ81880; 23) T/A ENDO PACK, REF DYNJ83158; 24) JVL - MODULE T A PK, REF DYNJ84083; 25) T&A, REF DYNJ900289J; 26) T&A, REF DYNJ900289J; 27) T & A, REF DYNJ902626G; 28) LARYNGOSCOPY BRONCH-LF, REF DYNJ903264A; 29) T&A, REF DYNJ903428J; 30) T&A, REF DYNJ903428J; 31) PEDI ENT - OAKBEND, REF DYNJ905769; 32) T & A, REF DYNJ907056C; 33) ASC FARRELL T&A, REF DYNJ908132; 34) CHS ENT PACK, REF DYNJCH500
Product code: OGR Ear, Nose, And Throat Surgical Tray
Reason for recall: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Quantity in commerce: 2740 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product codes and lots: 1) REF CDS982091I, UDI/DI 40193489741644 (each), 10193489741643 (case), Lot Numbers: 24BBA623; 2) REF CDS984492B, UDI/DI 40193489637183 (each), 10193489637182 (case), Lot Numbers: 24ABB114; 3) REF DYNJ0798129I, UDI/DI 40195327226511 (each), 10195327226510 (case), Lot Numbers: 23KBB859; 4) REF DYNJ30591I, UDI/DI 40193489962841 (each), 10193489962840 (case), Lot Numbers: 24ABD228; 5) REF DYNJ37171A, UDI/DI 40884389750620 (each), 10884389750629 (case), Lot Numbers: 23KBD998; 6) REF DYNJ40836F, UDI/DI 40195327059539 (each), 10195327059538 (case), Lot Numbers: 23LBQ627; 7) REF DYNJ44249J, UDI/DI 40195327483020 (each), 10195327483029 (case), Lot Numbers: 23KBE536; 8) REF DYNJ44349L, UDI/DI 40195327394531 (each), 10195327394530 (case), Lot Numbers: 23KBD353; 9) REF DYNJ44349M, UDI/DI 40195327564378 (each), 10195327564377 (case), Lot Numbers: 24ABA446; 10) REF DYNJ53200C, UDI/DI 40193489779371 (each), 10193489779370 (case), Lot Numbers: 23KBC298; 11) REF DYNJ53270C, UDI/DI 40193489812566 (each), 10193489812565 (case), Lot Numbers: 23KBA462; 12) REF DYNJ54610A, UDI/DI 40195327456451 (each), 10195327456450 (case), Lot Numbers: 24ABD026; 13) REF DYNJ55255C, UDI/DI 40195327493753 (each), 10195327493752 (case), Lot Numbers: 23KBD956; 14) REF DYNJ58979, UDI/DI 40889942914938 (each), 10889942914937 (case), Lot Numbers: 24ABD861; 15) REF DYNJ62927, UDI/DI 40193489700245 (each), 10193489700244 (case), Lot Numbers: 23LBQ806; 16) REF DYNJ63190A, UDI/DI 40193489304603 (each), 10193489304602 (case), Lot Numbers: 23LBN122; 17) REF DYNJ66274A, UDI/DI 40195327151981 (each), 10195327151980 (case), Lot Numbers: 24ABB272; 18) REF DYNJ67109B, UDI/DI 40195327207084 (each), 10195327207083 (case), Lot Numbers: 24ABC426; 19) REF DYNJ68417C, UDI/DI 40195327341634 (each), 10195327341633 (case), Lot Numbers: 23KBC605; 20) REF DYNJ80227B, UDI/DI 40195327220144 (each), 10195327220143 (case), Lot Numbers: 24ABC423; 21) REF DYNJ80559A, UDI/DI 40195327512522 (each), 10195327512521 (case), Lot Numbers: 23LBP334; 22) REF DYNJ81880, UDI/DI 40195327153671 (each), 10195327153670 (case), Lot Numbers: 24ABE284; 23) REF DYNJ83158, UDI/DI 40195327236886 (each), 10195327236885 (case), Lot Numbers: 23LBU511; 24) REF DYNJ84083, UDI/DI 40195327332236 (each), 10195327332235 (case), Lot Numbers: 23LBL823; 25) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABS131; 26) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABE249; 27) REF DYNJ902626G, UDI/DI 40195327214334 (each), 10195327214333 (case), Lot Numbers: 24ABU280; 28) REF DYNJ903264A, UDI/DI 40889942632566 (each), 10889942632565 (case), Lot Numbers: 23LBF682; 29) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24CBI692; 30) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24ABS337; 31) REF DYNJ905769, UDI/DI 40193489507998 (each), 10193489507997 (case), Lot Numbers: 24ABS137; 32) REF DYNJ907056C, UDI/DI 40195327276875 (each), 10195327276874 (case), Lot Numbers: 24ABA207; 33) REF DYNJ908132, UDI/DI 40193489981521 (each), 10193489981520 (case), Lot Numbers: 24CBA800; 34) REF DYNJCH500, UDI/DI 40884389900421 (each), 10884389900420 (case), Lot Numbers: 23LBP611

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0160-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0149-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0150-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0151-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0152-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0153-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0154-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0155-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0156-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0157-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0158-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0159-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0160-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0161-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0162-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0163-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0164-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0165-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0166-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0167-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0168-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0169-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0170-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0171-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0172-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0173-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0174-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0175-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0176-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0177-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0178-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0179-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23
Z-0180-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23

Product code OGR

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)