Medline brand medical procedure convenience kits — Class II medical device recall Z-0161-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0161-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 5,972 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10080196120680, 10193489848328, 10193489849554, 10193489862904, 10193489956795, 10193489969658, 10193489973266, 10193489974928, 10193489995671, 10195327005191, 10195327054267, 10195327061852, 10195327076610, 10195327199487, 10195327236854, 10195327243227, 10195327246808, 10195327312145, 10195327325947, 10195327372279, 10195327385279, 10195327416768, 10195327420772, 10195327429904, 10195327498252 and 37 more |
| Lot numbers | 23KBC527, 23KBC919, 23KBD028, 23KBQ852, 23KBT202, 23KBU714, 23LBL444, 23LBL736, 23LBM079, 23LBM976, 23LBN301, 23LBO542, 23LBO773, 23LBP094, 23LBP204, 23LBP883, 23LBR366, 23LBS108, 23LBU050, 23LBU911, 23LBV474, 24ABA628, 24ABC507, 24ABD664, 24ABG210, 24ABG332, 24ABG464, 24ABG713, 24ABJ966, 24ABN216, 24ABS212, 24ABU214, 24ABW238 |
| Model numbers | CDS983525D, DYNJ25834B, DYNJ35569C, DYNJ40724D, DYNJ41105C, DYNJ42132A, DYNJ43380A, DYNJ46716, DYNJ47821F, DYNJ48978C, DYNJ50428C, DYNJ53418B, DYNJ55479D, DYNJ58445A, DYNJ58566B, DYNJ59431, DYNJ60077A, DYNJ62111C, DYNJ65830A, DYNJ66821A, DYNJ68883, DYNJ69729, DYNJ80004, DYNJ80763, DYNJ82626 and 6 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0161-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.