{"source":"fda-device-recalls","note":"Free 5-item preview. The full feed is $0.05/call at GET /v1/fda-device-recalls/changes.","question":"Which FDA medical-device recalls / enforcement actions were reported since T, and how serious (recall class) are they?","sample":[{"source":"fda-device-recalls","entityId":"fda-device-recalls:Z-2522-2026","type":"recall","title":"Class II: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A (Philips North America Llc)","summary":"Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.905Z","effectiveDate":"2026-05-26","sourceUrl":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2026%22","detail":{"classification":"Class II","firm":"Philips North America Llc","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"MA","country":"United States"}},{"source":"fda-device-recalls","entityId":"fda-device-recalls:Z-2587-2026","type":"recall","title":"Class II: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F (Medline Industries, LP)","summary":"Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.905Z","effectiveDate":"2026-02-27","sourceUrl":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2587-2026%22","detail":{"classification":"Class II","firm":"Medline Industries, LP","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"IL","country":"United States"}},{"source":"fda-device-recalls","entityId":"fda-device-recalls:Z-2562-2026","type":"recall","title":"Class II: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powere (SURGIFY MEDICAL OY)","summary":"Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.905Z","effectiveDate":"2026-04-30","sourceUrl":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2562-2026%22","detail":{"classification":"Class II","firm":"SURGIFY MEDICAL OY","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"N/A","country":"Finland"}},{"source":"fda-device-recalls","entityId":"fda-device-recalls:Z-2601-2026","type":"recall","title":"Class I: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product (Abiomed, Inc.)","summary":"Potential for thrombus formation during prolonged use of the introducer. Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.. Status: Ongoing (Voluntary: Firm initiated).","significance":9,"detectedAt":"2026-07-14T22:21:20.905Z","effectiveDate":"2026-05-22","sourceUrl":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2601-2026%22","detail":{"classification":"Class I","firm":"Abiomed, Inc.","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"MA","country":"United States"}},{"source":"fda-device-recalls","entityId":"fda-device-recalls:Z-2591-2026","type":"recall","title":"Class II: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B (Medline Industries, LP)","summary":"Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.. Status: Ongoing (Voluntary: Firm initiated).","significance":6,"detectedAt":"2026-07-14T22:21:20.905Z","effectiveDate":"2026-02-27","sourceUrl":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2026%22","detail":{"classification":"Class II","firm":"Medline Industries, LP","status":"Ongoing","voluntaryMandated":"Voluntary: Firm initiated","state":"IL","country":"United States"}}]}