{"recall":{"id":"fda-device-99613","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medical Action Industries, Inc. 306 recalls 2 products","firm":"Medical Action Industries, Inc. 306","date":"2026-07-23","reported":"2026-09-16","status":"Ongoing","classification":"Class I","products":[{"name":"Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules","code":"UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)","quantity":"1,960","number":"Z-3106-2026","classification":"Class I"},{"name":"Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules","code":"REF/UDI-DI/Lot(Expiration Date): 59553/10809160010518/330274(9/1/2026), 331036(11/1/2026), 332995(11/1/2026), 333957(11/1/2026), 338894(11/1/2026); 83945B/10809160444269/330827(10/10/2026), 330907(10/10/2026), 333956(11/1/2026), 350340(11/1/2026), 351266(11/30/2026), 373674(5/31/2027)","quantity":"3,606","number":"Z-3107-2026","classification":"Class I"}],"reason":"Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US distribution to states of: IA, VA, MO, KS, FL, OH and LS.","nationwide":false,"states":["FL","IA","KS","MO","OH","VA"],"units":"1,960; 3,606","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=99613","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bea01f646df4a848","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=99613","record":[{"status":"Ongoing","city":"Arden","state":"NC","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99613","recalling_firm":"Medical Action Industries, Inc. 306","address_1":"25 Heywood Rd","address_2":"","postal_code":"28704-9302","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US distribution to states of: IA, VA, MO, KS, FL, OH and LS.","recall_number":"Z-3106-2026","product_description":"Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules","product_quantity":"1,960","reason_for_recall":"Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.","recall_initiation_date":"20260723","center_classification_date":"20260909","report_date":"20260916","code_info":"UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)","more_code_info":""},{"status":"Ongoing","city":"Arden","state":"NC","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99613","recalling_firm":"Medical Action Industries, Inc. 306","address_1":"25 Heywood Rd","address_2":"","postal_code":"28704-9302","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US distribution to states of: IA, VA, MO, KS, FL, OH and LS.","recall_number":"Z-3107-2026","product_description":"Kit: Single Shot Epidural 20/Cs, REF: 59553;  Kit: Single Shot Epidural 20/Cs, REF: 83945B.  Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules","product_quantity":"3,606","reason_for_recall":"Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.","recall_initiation_date":"20260723","center_classification_date":"20260909","report_date":"20260916","code_info":"REF/UDI-DI/Lot(Expiration Date): 59553/10809160010518/330274(9/1/2026), 331036(11/1/2026), 332995(11/1/2026), 333957(11/1/2026), 338894(11/1/2026);  83945B/10809160444269/330827(10/10/2026), 330907(10/10/2026), 333956(11/1/2026), 350340(11/1/2026), 351266(11/30/2026), 373674(5/31/2027)","more_code_info":""}]}}