Z-0158-2025Class II

Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY...

Name: Z-0158-2025 Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY...
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: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK... 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-0158-2025
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: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129
Product code: OFG Ct Biopsy 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: 2,426 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product codes and lots: a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers: 23KBF936; b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers: 23LBI584; c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers: 23LBP833; d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers: 23LBN740; e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers: 23LBP401; f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers: 23KBD517; g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers: 23LBR787; h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers: 24ABA444; i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers: 23LBL347; j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers: 24ABA492; k) REF DYNJ68393A, UDI/DI 40193489939997 (each), 10193489939996 (case), Lot Numbers: 23LBL431; l) REF DYNJ84129, UDI/DI 40195327334544 (each), 10195327334543 (case), Lot Numbers: 23KBB926

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0158-2025
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 OFG

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)