The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

576–600 of 26383

  • HighFDA (Devices)·Z-1836-2026·2026-04-29

    [pending] Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP

    Pending LLM rewrite. Source: FDA_DEVICE Z-1836-2026.

    Product
    Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk

    Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2026·2026-04-29

    LeadCare II Blood Lead Test Kit Recall for Inaccurate Results

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.

    Product
    (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2026·2026-04-29

    LeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results

    Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.

    Product
    LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2026·2026-04-29

    Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR

    Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.

    Product
    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1884-2026·2026-04-29

    Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design

    Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2026·2026-04-29

    Medline General Laparoscopy Kit regulatory clearance rescinded

    The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.

    Product
    Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2026·2026-04-29

    CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness

    Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.

    Product
    CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2026·2026-04-29

    Pantoprazole Sodium Tablets Recalled for Discoloration Issues

    Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2026·2026-04-29

    Medline Hysteroscopy and Sling Packs subject to regulatory rescission

    FDA has rescinded 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in two Medline medical device kits distributed nationwide.

    Product
    Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2026·2026-04-29

    Flamingo Funnel Large surgical smoke evacuation device recall

    SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

    Product
    Flamingo Funnel Large, Model Number SQ20012-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1901-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2026·2026-04-29

    Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive

    Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.

    Product
    ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)25121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2026·2026-04-29

    Soft-Vu Angiographic Catheter Cobra Non-Braided recalled by Angiodynamics

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2026·2026-04-29

    Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1848-2026·2026-04-29

    Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances

    Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1897-2026·2026-04-29

    nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life

    XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.

    Product
    nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2026·2026-04-29

    Medline Breast Pack Kit regulatory clearance rescinded by FDA

    The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.

    Product
    Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2026·2026-04-29

    Medline Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA clearance. The recall affects 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
    Category
    Medical Device
    Distribution
    Distributed nationwide