Medical DeviceJun 24, 2026
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm recall — FDA Z-2471-2026
Potential for overpressure alerts.
Class IIFDA: OngoingConMed Corporation
June 2026 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceJun 24, 2026
HeartMate 3 Left Ventricular System (LVAS) Kits recall — FDA Z-2518-2026
Due to 11 volt Backup Battery failures.
Class IIFDA: OngoingThoratec LLC
Medical DeviceJun 24, 2026
ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length recall — FDA Z-2466-2026
Potential for overpressure alerts.
Class IIFDA: OngoingConMed Corporation
Medical DeviceJun 24, 2026
ARROW INTERNATIONAL Description/REF: PARACENTESIS KIT/ASK-00376-JHH recall — FDA Z-2386-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of…
Class IFDA: OngoingARROW INTERNATIONAL, LLC
Medical DeviceJun 24, 2026
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C recall — FDA Z-2436-2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
HeartMate 3" System Controller recall — FDA Z-2519-2026
Due to 11 volt Backup Battery failures.
Class IIFDA: OngoingThoratec LLC
Medical DeviceJun 24, 2026
Medline convenience kits: DAVINCI MAIN DYNJ908031D recall — FDA Z-2434-2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
ARROW INTERNATIONAL Description/REF: ACCESS TRAY/GU-04020 recall — FDA Z-2385-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of…
Class IFDA: OngoingARROW INTERNATIONAL, LLC
Medical DeviceJun 24, 2026
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit recall — FDA Z-2485-2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish,…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
ARROW INTERNATIONAL Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F recall — FDA Z-2388-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of…
Class IFDA: OngoingARROW INTERNATIONAL, LLC
Medical DeviceJun 24, 2026
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE recall — FDA Z-2438-2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
Howmedica Osteonics TRI TS BASEPLATE SIZE 3 recall — FDA Z-2461-2026
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon…
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceJun 24, 2026
Abiomed Impella CP Set with SmartAssist recall — FDA Z-2457-2026
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Class IFDA: OngoingAbiomed, Inc.
Medical DeviceJun 24, 2026
ARROW INTERNATIONAL Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1 recall — FDA Z-2371-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of…
Class IFDA: OngoingARROW INTERNATIONAL, LLC
Medical DeviceJun 24, 2026
ARROW INTERNATIONAL Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC recall — FDA Z-2379-2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of…
Class IFDA: OngoingARROW INTERNATIONAL, LLC
Medical DeviceJun 24, 2026
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG recall — FDA Z-2487-2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish,…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU recall — FDA Z-2496-2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish,…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceJun 24, 2026
Inspire stimulation Lead recall — FDA Z-2516-2026
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may…
Class IIFDA: OngoingInspire Medical Systems Inc.
Medical DeviceJun 24, 2026
Medtronic O-arm O2 Imaging System recall — FDA Z-2451-2026
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Class IIFDA: OngoingMedtronic Navigation, Inc.-Boxborough
Medical DeviceJun 24, 2026
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B recall — FDA Z-2486-2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish,…
Class IIFDA: OngoingMedline Industries, LP
DrugJun 24, 2026
Dabur India Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 recall — FDA D-0635-2026
CGMP Deviations; deficiencies observed during FDA inspection
Class IIFDA: OngoingDabur India Limited
DrugJun 24, 2026
PAI Holdings VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams recall — FDA D-0592-2026
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class IIFDA: OngoingPAI Holdings LLC
DrugJun 24, 2026
Dabur India Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin recall — FDA D-0631-2026
CGMP Deviations; deficiencies observed during FDA inspection
Class IIFDA: OngoingDabur India Limited
DrugJun 24, 2026
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg recall — FDA D-0588-2026
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.