Z-0161-2025Class II

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF...

Name: Z-0161-2025 Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF...
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) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4)... 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-0161-2025
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) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B
Product code: FDE Laparoscopy Kit
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: 5972 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product codes and lots: 1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883; 12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301; 13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279 (case), Lot Numbers: 23LBO773; 14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444; 15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911; 16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919; 17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210; 18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542; 19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204; 20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366; 21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852; 22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527; 23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664; 24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094; 25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464; 26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050; 27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216; 28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474; 29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214; 30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966; 31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202; 32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079; 33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2025
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 FDE

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)