{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197503", "product_res_number": "Z-0930-2023", "event_date_initiated": "2022-11-18", "event_date_posted": "2023-01-11", "recall_status": "Open, Classified", "res_event_number": "91317", "product_code": "GFA", "product_description": "Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number.\n\na. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; \n\nb. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; \n\nc. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; \n\nd. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; \n\ne. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; \n\nf. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; \n\ng. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS; \n\nh. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR; \n\ni. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS; \n\nj. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS; \n\nk. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS. \n\n\n***Expansion on 02/06/2023 with the following additional products:\nl. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS; \n\nm. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS; \n\nn. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS; \n\no. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS.\n\nIndicated for use in surgical procedures where tissue separation is necessary.", "code_info": "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; \n\nb. Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/GTIN: 20193489090113, Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435; \n\nc. Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/GTIN: 20193489090137, Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470; \n\nd. Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/GTIN: 20193489090151, Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584; \n\ne. Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/GTIN: 20193489090144, Lot Number: Z01076; \n\nf. 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; \n\ng. 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; \n\nh. Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/GTIN: 20193489090199, Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385; \n\ni. Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/GTIN: 20193489090236, Lot Numbers: Z00343, Z02530; \n\nj. Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/GTIN: 20193489090267, Lot Numbers: Z01064, Z02417, Z02417, Z02198; \n\nk. Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/GTIN: 20193489090281, Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355. \n\n***Expansion on 02/06/2023 with the following additional products:\nl. Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/GTIN: 20193489090175, Lot Number: Z01277; \n\nm. Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/GTIN: 20193489090212, Lot Numbers: Z01206, Z02485, Z02550; \n\nn. Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/GTIN: 20193489090243, Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658; \n\no. Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/GTIN: 20193489090250, Lot Number: Z00312.", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Karin Johnson\n866-359-1704", "reason_for_recall": "Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.", "root_cause_description": "Under Investigation by firm", "action": "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.", "product_quantity": "76,053 units", "distribution_pattern": "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.", "openfda": { "k_number": [ "K821487", "K811506", "K931210", "K954483", "K955229", "K933298", "K854192", "K934390", "K861876", "K931769", "K802838", "K971978", "K924953", "K820601", "K933595", "K863788", "K830434", "K810045", "K935391", "K912761", "K934603", "K851880", "K953012", "K896280", "K950403", "K940501", "K831714" ], "registration_number": [ "1828100", "", "8043971", "3003724410", "1318997", "1649518", "3009051471", "3014615644", "3008951116", "3009732568", "3006498370", "3021477808", "3031240334", "3011024991", "8031020", "3007515069", "9616696", "3004450489", "3015495690", "2183744", "1054241", "3009599228", "8010298", "3015440604", "1043653", 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"General, Plastic Surgery", "regulation_number": "878.4820", "device_class": "1" } } ] }