{ "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": "215404", "product_res_number": "Z-2452-2025", "event_date_initiated": "2025-07-08", "event_date_posted": "2025-08-27", "recall_status": "Open, Classified", "res_event_number": "97371", "product_code": "LRO", "k_numbers": [ "K213481" ], "product_description": "The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.", "code_info": "1. SKU CDS983907M\nUDI 10195327584498 (ea)\n40195327584499 (case)\nKit lots:\n24CBV474\n24EBS619\n24FBS722\n24IBG491\n24JBV978\n25ABK333\n25ABP110;\n\n2. SKU CDS983907N\nUDI 10198459239168 (ea)\n40198459239169 (case)\nKit lots:\n25CBI861\n25EBH846\n\n3. SKU DYNJ69405B\nUDI 10198459281655 (ea)\n40198459281656 (case)\nKit lots:\n25DMG402\n25FMB391;\n\n4. SKU DYNJ89705\nUDI 10198459282133 (ea)\n40198459282134 (case)\nKit lot:\n25CMH791;\n\n5. SKU DYNJ910547\nUDI 10198459031212 (ea)\n40198459031213 (case)\nKit lots:\n24HMK260\n24IMH458\n24JMB661\n24JMC663\n24JMH740\n24JMJ718\n24KMH904\n25AMF426\n25BMC308\n25CMC866\n25CMD885\n25CMJ685\n25DMC390;\n\n6. SKU DYNJ911008\nUDI 10198459233623 (ea)\n40198459233624 (case)\nKit lots:\n25DBT802;\n\n7. SKU DYNJ9682800V\nUDI 10195327257248 (ea)\n40195327257249 (case)\nKit lots:\n24EDA813\n24FDA466\n24GDA325\n24IDB396\n24JDB676", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "reason_for_recall": "Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.", "root_cause_description": "Unknown/Undetermined by firm", "action": "On July 8, 2025, the firm communicated the recall to customers who had received affected kits. Medline instructed customers to request stickers to over-label the affected convenience kits with a warning label, indicating to remove the affected component and replace it with product from supply. No kits are to be returned.", "product_quantity": "1145", "distribution_pattern": "US Nationwide distribution tin the states of CA, FL, IA, and TX.", "openfda": { "k_number": [ "K890098", "K931844", "K890729", "K932217", "K880942", "K944044", "K930700", "K931673", "K871459", "K883250", "K914037", "K890726", "K950574", "K882684", "K914036", "K951478", "K920292", "K934688", "K952539", "K895202", "K963443", "K931760", "K041080", "K961683", "K964921", "K854095", "K871873", "K933137", "K892389", "K935740", "K934029", "K893814", "K964011", "K914174", "K872011", "K023276", "K971062", "K922133", "K890570", "K902888", "K925214", "K965201", "K941846", "K931759", "K934028", "K951149", "K932220", "K963715", "K935741", "K922648", "K932652", "K931758", "K920267", "K923600", "K934030", "K980137", "K873973", "K931820", "K871434", "K212258", "K890658", "K854292", "K871322", "K970286", "K913136", "K905459", "K963721", "K930270", "K871437", "K880961", "K926269", "K935743", "K902293", "K842648", 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"1000160458", "3018077422", "1923569", "1643817", "1417592", "3027977504", "3005596530", "3045816907", "3011270181", "3003005156", "3018116884", "3026197444", "3004605321", "3014680744", "3002806603", "3015173212", "3002807308", "3003807323", "3003015552", "3013600605", "3004829691", "3014925393", "2011171", "3002805559", "3005669815", "1000124971", "3007829657", "3010376936", "3002807314", "3003803331", "3019798849", "3006540014", "1928237", "1000112877", "3011532690", "3043620414", "3009888344", "3005595283", "3013421458", "3017636737", "3006450239", "3005012805", "3003040625", "1823410", "2648727", "2000028362", "3001717360", "1018470", "3000215259", "3002902735", "1000113384", "3005391805", "3042480961", "3010878085", "3011545608" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }