The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

576–600 of 21557

  • 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-1914-2026·2026-04-29

    Arrow Pressure Injectable Central Venous Catheters Recalled

    Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2026·2026-04-29

    Medline Arthroscopy Pack regulatory clearance rescinded

    The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.

    Product
    Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2026·2026-04-29

    Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern

    B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
    Category
    Drug
    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-1918-2026·2026-04-29

    Rover Mobile X-ray System may malfunction and become inoperable

    Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.

    Product
    Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0667-2026·2026-04-29

    Chips Ahoy Baked Bites Brookie recalled over hard corn starch lumps

    CHIPS AHOY! Baked Bites Brookie cartons are being recalled because hard corn starch lumps were found in the product. 437 cases are affected.

    Product
    CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
    Category
    Food
    Distribution
    11 states
  • 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-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 (Drugs)·D-0493-2026·2026-04-29

    Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications

    The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.

    Product
    OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2026·2026-04-29

    Medline Angio Cath Pack regulatory clearance rescinded nationwide

    Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.

    Product
    Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
    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-1888-2026·2026-04-29

    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.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
    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 (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 (Food)·H-0669-2026·2026-04-29

    Bombay Kitchen Tikka Sev contains undeclared FD&C colors

    Bombay Kitchen brand Tikka Sev is being recalled because the product contains undeclared colors, FD&C Yellow #6 and FD&C Red #40. 53 cases are affected.

    Product
    Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port
    Category
    Food
    Distribution
    1 state
  • 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-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-1830-2026·2026-04-29

    Medline Namic Control Syringes recalled due to rescinded FDA clearance

    Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 units distributed nationwide.

    Product
    Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
    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-1899-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2026·2026-04-29

    Flamingo Funnel Small surgical device recalled for sterilization defect

    SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.

    Product
    Flamingo Funnel Small, Model Number SQ20012-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0670-2026·2026-04-29

    Bombay Kitchen Punjabi Mix contains undeclared FD&C colors

    Bombay Kitchen brand Punjabi Mix is being recalled because the product contains undeclared colors, FD&C Yellow #6 and FD&C Red #40. 69 cases are affected.

    Product
    Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Chana Dal (Split Bengal Gram), Brown Lentils (Masoor), Chickpeas, Rice Flakes, Puffed Rice, Spices, Sugar, Peanuts, Raisins, Yogurt (pasteurized Grade A M
    Category
    Food
    Distribution
    1 state
  • 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