Medline Convenience kits used for various procedures: 1) OCULOPLASTIC… — Class II medical device recall Z-1600-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1600-2025 |
|---|---|
| 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 | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 4,094 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489238655, 10193489243826, 10193489288940, 10193489318128, 10193489449532, 10193489672763, 10193489754704, 10193489757330, 10193489823554, 10193489916355, 10195327209704, 10195327345075, 10195327444075, 10195327467708, 10195327468828, 10195327631321, 10198459166037, 10884389380406, 10884389722176, 10884389871652, 10889942108534, 10889942116553, 10889942213542, 10889942437078, 40193489238656 and 23 more |
| Lot numbers | 24IBH633, 24IBH739, 24IBH802, 24IBL195, 24IBR304, 24JBL025, 24JBM075, 24JBM318, 24JBM914, 24JBT528, 24JBT877, 24JBV138, 24JBV645, 24JBV846, 24JBW152, 24JBW480, 24JBX780, 24JBX789, 24KBA440, 24KBB123, 24KBB906, 24KBC573, 24KBC625, 24KBC670, 24KBC738, 24KBC750, 24KBC752, 24KBE585, 24KBF385, 24KBF775, 24KBH241, 24KBH367, 24KBI482 |
| Model numbers | DYNJ34160D, DYNJ34199A, DYNJ35741D, DYNJ37142D, DYNJ37231B, DYNJ37316D, DYNJ38907, DYNJ40620F, DYNJ43914B, DYNJ46737A, DYNJ52658D, DYNJ55985D, DYNJ57440D, DYNJ63696, DYNJ63753, DYNJ64712B, DYNJ64886A, DYNJ65109, DYNJ66056, DYNJ66212A, DYNJ67772A, DYNJ67882, DYNJ68328, DYNJ84991 |
Product
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 7) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 8) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 9) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 10) FACE PACK, Model Number: DYNJ37316D; 11) PLASTIC PACK-LF, Model Number: DYNJ57440D; 12) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 13) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 14) SATELLITE MINOR PLASTIC PACK, Model Number: DYNJ63696; 15) FACIAL/EYE PACK, Model Number: DYNJ68328; 16) BREAST PACK, Model Number: DYNJ63753; 17) BREAST PACK, Model Number: DYNJ63753; 18) TUMMY PACK, Model Number: DYNJ64886A; 19) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 20) PLASTIC BREAST PACK, Model Number: DYNJ40620F; 21) PLASTIC ENT PACK, Model Number: DYNJ64712B; 22) PLASTIC SURGERY SERV-DR GARAZO, Model Number: DYNJ34199A; 23) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 24) OCULAR PLASTICS, Model Number: DYNJ55985D; 25) TUMMY PACK, Model Number: DYNJ64886A; 26) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 27) ZURI BREAST PACK, Model Number: DYNJ67772A; 28) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 29) TUMMY PACK, Model Number: DYNJ64886A; 30) OCCULAR PLASTIC PACK, Model Number: DYNJ35741D; 31) FACELIFT PACK, Model Number: DYNJ38907; 32) BREAST PACK, Model Number: DYNJ67882; 33) KDOP PLASTIC PACK, Model Number: DYNJ37142D
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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-1600-2025. 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.