Medline CISION Sterile Blades — Class II medical device recall Z-0930-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-01-18, distributed nationwide. Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
| Recall number | Z-0930-2023 |
|---|---|
| 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 | 2022-11-18 |
| Classified | 2023-01-11 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 76,053 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 20193489090106, 20193489090113, 20193489090137, 20193489090144, 20193489090151, 20193489090175, 20193489090182, 20193489090199, 20193489090205, 20193489090212, 20193489090236, 20193489090243, 20193489090250, 20193489090267, 20193489090281, 30193489090103, 30193489090110, 30193489090134, 30193489090141, 30193489090158, 30193489090172, 30193489090189, 30193489090196, 30193489090202, 30193489090219 and 5 more |
| Lot numbers | Y01848, Y01853, Y01861, Y03382, Y03404, Z00300, Z00312, Z00320, Z00331, Z00343, Z00381, Z00385, Z00402, Z01064, Z01076, Z01206, Z01260, Z01277, Z01513, Z02183, Z02188, Z02195, Z02198, Z02202, Z02233, Z02246, Z02259, Z02261, Z02263, Z02288, Z02290, Z02320, Z02339, Z02346, Z02355, Z02364, Z02377, Z02403, Z02409, Z02416 and 18 more |
| Model numbers | CISION10CS, CISION10CSR, CISION11CS, CISION11CSR, CISION11SS, CISION12SS, CISION15CS, CISION15CSR, CISION15SS, CISION20CS, CISION20SS, CISION21CS, CISION21SS, CISION22CS, CISION22SS |
Product
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; g. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS; h. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR; i. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS; j. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS; k. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS. ***Expansion on 02/06/2023 with the following additional products: l. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS; m. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS; n. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS; o. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS. Indicated for use in surgical procedures where tissue separation is necessary.
Reason for recall
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
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-0930-2023. 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.