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.

601–625 of 21557

  • 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-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 (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-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-1900-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2026·2026-04-29

    Medline Catheterization and Angiography Kits Regulatory Clearance Rescinded

    Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.

    Product
    Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT57
    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
    2 states
  • 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-1921-2026·2026-04-29

    IV Administration Sets and Gravity Infusion Kits Risk Backflow

    Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kits (Part Number AMS14994A) due to a potential for backflow of medication from secondary IV containers into primary IV containers. The recall affects 520 units distributed nationwide.

    Product
    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2026·2026-04-29

    Medline Heart Transplant Biopsy Kit regulatory clearance rescinded

    Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.

    Product
    Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
    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-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 (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-1810-2026·2026-04-22

    LinkBio CORE Workstation may display an incorrect planning date

    LinkBio is recalling the CORE Workstation, a component of the CORE Shoulder System, because it may display an incorrect planning date on the Start Case menu screen.

    Product
    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0462-2026·2026-04-22

    MGC Health 30-count honey lemon cough drops recalled after inspection findings

    MGC Health Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 30-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    MGC HEALTH — MGC HEALTH (COUGH DROPS HONEY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2026·2026-04-22

    Rhonda Allison calming skin gel recalled as a subpotent hydrocortisone product

    Essential Calming Skin Gel containing 1% hydrocortisone is being recalled because the product is subpotent. The action covers 299 bottles.

    Product
    Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0664-2026·2026-04-22

    Bee Well wildflower honey recalled after testing high for C4 sugars

    Bee Well Raw & Unfiltered Wildflower Honey is being recalled after FDA sample results were positive for a high C4 sugar content.

    Product
    Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0465-2026·2026-04-22

    Quality Choice cherry cough drops recalled after facility inspection findings

    QC Quality Choice Menthol Cough Suppressant Oral Anesthetic Cough Drops, cherry flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0456-2026·2026-04-22

    Exchange Select honey lemon cough drops recalled after facility inspection findings

    Exchange Select Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 30-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    HONEY LEMON FLAVOR COUGH DROP — HONEY LEMON FLAVOR COUGH DROP (HONEY LEMON FLAVOR COUGH DROP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2026·2026-04-22

    Quality Choice menthol cough drops recalled after facility inspection findings

    QC Quality Choice Menthol Cough Suppressant Oral Anesthetic Cough Drops, menthol flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0464-2026·2026-04-22

    Quality Choice sugar free black cherry cough drops recalled after inspection findings

    QC Quality Choice sugar free Menthol Cough Suppressant Oral Anesthetic Cough Drops, black cherry, 25-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2026·2026-04-22

    Menthol Flavor Cough Drops Recalled Due to Potential Product Quality Issues

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd. is recalling Menthol Flavor Cough Drops due to quality concerns identified during an FDA inspection.

    Product
    MENTHOL FLAVOR COUGH DROP — MENTHOL FLAVOR COUGH DROP (MENTHOL FLAVOR COUGH DROP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2026·2026-04-22

    Apotek desmopressin nasal spray recalled over dislodged or missing cap liners

    Apotek is recalling one lot of Desmopressin Nasal Spray, USP because of a defect in a batch of bottle caps involving dislodged or missing cap liners.

    Product
    DESMOPRESSIN ACETATE — DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0458-2026·2026-04-22

    Caring Mill cherry cough drops recalled after facility inspection findings

    Caring Mill Menthol Cough Suppressant Oral Anesthetic Cough Drops, cherry, 90-count bags, are being recalled following FDA observations at the manufacturing facility.

    Product
    CARING MILL COUGH DROPS CHERRY — CARING MILL COUGH DROPS CHERRY (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide