Medline CISION Sterile Blades. Labeled as follows with… recallZ-0930-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline notified customers on about 11/18/2022, via letter. Customers were instructed to immediately check stock for the affected item number and the affected lot numbers, and to destroy all affected product. Customers were also instructed to notify customers if the product was further distributed and to complete a response form. On 02/06/2023, the recall was expanded to include additional item numbers and consignees were notified.
Recall details
- Recall number
- Z-0930-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Jan 11, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 76,053 units
- Product code
- GFA
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
a. Item Number: CISION10CS, Box UDI/GTIN: 30193489090103, Case UDI/GTIN: 20193489090106, Lot Numbers: Y01853, Z00300, Z02246, Z02288, Z02290, Z02416, Z02246, Z02473, Z02290, Z02290, Z02290, Z02290; b. Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/GTIN: 20193489090113, Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435; c. Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/GTIN: 20193489090137, Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470; d. Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/GTIN: 20193489090151, Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584; e. Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/GTIN: 20193489090144, Lot Number: Z01076; f. Item Number: CISION15SS, Box UDI/GTIN: 30193489090202, Case UDI/GTIN: 20193489090205, Lot Numbers: Y01861, Z00320, Z02233, Z02492, Z02409, Z02409, Z02409, Z02409, Z02409, Z02482, Z00331, Z02233, Z02377, Z02377, Z02377, Z02377, Z02409, Z02409, Z02409, Z02482; g. Item Number: CISION15CS, Box UDI/GTIN: 30193489090189, Case UDI/GTIN: 20193489090182, Lot Numbers: Y01848, Y03404, Z02188, Z02611, Z02611, Z02188, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611; h. Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/GTIN: 20193489090199, Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385; i. Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/GTIN: 20193489090236, Lot Numbers: Z00343, Z02530; j. Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/GTIN: 20193489090267, Lot Numbers: Z01064, Z02417, Z02417, Z02198; k. Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/GTIN: 20193489090281, Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355. ***Expansion on 02/06/2023 with the following additional products: l. Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/GTIN: 20193489090175, Lot Number: Z01277; m. Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/GTIN: 20193489090212, Lot Numbers: Z01206, Z02485, Z02550; n. Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/GTIN: 20193489090243, Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658; o. Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/GTIN: 20193489090250, Lot Number: Z00312.
Devices named in this recall
15 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline CISION15CSMedline Industries, Inc. · BLADE, SCALPEL1 recall2 reports
- Medline CISION10CSMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION15CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall1 report
- Medline CISION10CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION11CSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION11CSRMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION11SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION12SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION15SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION20CSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION20SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION21CSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION21SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION22CSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
- Medline CISION22SSMedline Industries, Inc. · BLADE, SCALPEL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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