{"recall":{"id":"fda-device-99643","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":true,"kind":"device","title":"CooperSurgical, Inc. recalls 2 products","firm":"CooperSurgical, Inc.","date":"2026-08-11","reported":"2026-09-30","status":"Ongoing","classification":"Class I","products":[{"name":"INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.","code":"1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722. 2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621. 3. Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760. 4. Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619. 5. Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.","quantity":"2,643 boxes (13,215 units)","number":"Z-3139-2026","classification":"Class I"},{"name":"INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.","code":"1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624. 2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057. 3. Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623. 4. Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625.","quantity":"149 boxes (745 units)","number":"Z-3140-2026","classification":"Class I"}],"reason":"Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.","nationwide":true,"states":[],"units":"2,643 boxes (13,215 units); 149 boxes (745 units)","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99643","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"394dd71df666bd99","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99643","record":[{"status":"Ongoing","city":"Trumbull","state":"CT","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99643","recalling_firm":"CooperSurgical, Inc.","address_1":"95 Corporate Dr","address_2":"","postal_code":"06611-1350","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.","recall_number":"Z-3139-2026","product_description":"INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.","product_quantity":"2,643 boxes (13,215 units)","reason_for_recall":"Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.","recall_initiation_date":"20260811","center_classification_date":"20260918","report_date":"20260930","code_info":"1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722.   2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621.   3.  Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760.   4.  Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619.   5.  Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.","more_code_info":""},{"status":"Ongoing","city":"Trumbull","state":"CT","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99643","recalling_firm":"CooperSurgical, Inc.","address_1":"95 Corporate Dr","address_2":"","postal_code":"06611-1350","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.","recall_number":"Z-3140-2026","product_description":"INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.","product_quantity":"149 boxes (745 units)","reason_for_recall":"Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.","recall_initiation_date":"20260811","center_classification_date":"20260918","report_date":"20260930","code_info":"1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624.   2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057.   3.  Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623.   4.  Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625.","more_code_info":""}]}}