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.

2351–2375 of 21589

  • ModerateFDA (Devices)·Z-0591-2025·2024-12-11

    BD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise

    BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.

    Product
    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2025·2024-12-11

    Boardwalk Antibacterial Handsoap Refill Recalled for Microbial Specification Failure

    Midlab Incorporated is recalling boardwalk Antibacterial Handsoap Refill due to out-of-specification microbial test results. Affected lot 0711241 was distributed nationwide.

    Product
    boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2025·2024-12-04

    FDA Drug Recall: LICEOUT Liquid Lice Treatment for Manufacturing Violations

    Neogen Corporation voluntarily recalled 5,328 sachets of LICEOUT lice treatment due to manufacturing practice violations. The product was distributed to Bob Barker Company for institutional facilities.

    Product
    LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0064-2025·2024-12-04

    Absorbine Jr Pain Relieving Knee Patch recalled for manufacturing deviations

    Unexo Life Sciences is recalling Absorbine Jr Pain Relieving Knee Patch nationwide due to manufacturing process deviations that do not meet FDA standards. No illnesses or injuries have been reported.

    Product
    ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0074-2025·2024-12-04

    Drug Lice Treatment Recalled Due to Manufacturing Practice Violations

    Neogen Corporation has voluntarily recalled LICEOUT liquid lice treatment due to manufacturing practice violations. The recall affects 8,328 jugs distributed to institutions.

    Product
    LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0558-2025·2024-12-04

    Medline Endo Kit Recall: Missing Lot and Expiration Date Labels

    Medline is recalling Endo Kit models containing Olympus components with missing sterile and manufacturing lot numbers and expiration dates on packaging. Without this labeling, medical facilities cannot verify product expiration or track inventory.

    Product
    ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0075-2025·2024-12-04

    Menthol pain relief patches recalled for manufacturing practice violations

    J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.

    Product
    Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2025·2024-12-04

    Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss

    Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.

    Product
    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0069-2025·2024-12-04

    LILAS Feminine Pain Relief Patch recalled for manufacturing violations

    Unexo Life Sciences is voluntarily recalling LILAS Feminine Pain Relief Patch nationwide due to manufacturing practice deviations affecting 363,300 patches.

    Product
    LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2025·2024-12-04

    Heart Device Transmitter Fails to Update Software After Power Interruption

    Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.

    Product
    Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0067-2025·2024-12-04

    Menthol Patch Recall Due to Manufacturing Quality Deviations

    HealthWise Menstrual Pain Relief Patch (Menthol 10%) is recalled due to manufacturing quality deviations. The firm-initiated recall affects 10,368 patches distributed nationwide in the US.

    Product
    HEALTHWISE MENSTRUAL PAIN RELIEF PATCH — HEALTHWISE MENSTRUAL PAIN RELIEF PATCH (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2025·2024-12-04

    Shimadzu Autosampler Devices Subject to Water Damage Affecting Main Board

    Water condensation may accumulate under the autosampler's thermal insulation and damage the main board, causing communication errors and delays in laboratory testing. Two Shimadzu models are affected: SIL-40C XR CL and SIL-40C X3 CL.

    Product
    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2025·2024-12-04

    GE Proteus XR/A radiographic system Wall Stand cable maintenance recall

    GE Healthcare is recalling certain Proteus XR/A radiographic systems because steel cables in the Wall Stand component have not been replaced at manufacturer-specified maintenance intervals.

    Product
    GE Proteus XR/A radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2025·2024-12-04

    JR Watkins Menthol Pain Relief Patches Recalled for Manufacturing Deviations

    JR Watkins Cooling Pain Relief Patches are being recalled due to manufacturing process deviations identified during production.

    Product
    JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0068-2025·2024-12-04

    Equate Maximum Strength Lidocaine Pain Relieving Patches Recalled for Manufacturing Deviations

    Equate Maximum Strength Lidocaine Pain Relieving Patches (4%) are being recalled due to current Good Manufacturing Practice deviations. Approximately 1.1 million patches were distributed nationwide in the US.

    Product
    EQUATE PAIN RELIEVING PATCHES — EQUATE PAIN RELIEVING PATCHES (LIDOCAINE 4%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0072-2025·2024-12-04

    Parche Leon pain relief patches recalled for manufacturing deviations

    Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.

    Product
    PARCHE LEON — PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0065-2025·2024-12-04

    THERACARE Lidocaine Pain Relief Patches Recalled for Manufacturing Deviations

    THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (4% lidocaine) is being recalled nationwide due to manufacturing practice deviations. Unexo Life Sciences, the manufacturer, voluntarily initiated the recall after identifying quality control issues.

    Product
    THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH — THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0066-2025·2024-12-04

    FDA Recalls Menthol Medicated Patches Due to Manufacturing Deviations

    FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.

    Product
    THERA CARE COLD HOT MEDICATED PATCH — THERA CARE COLD HOT MEDICATED PATCH (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2025·2024-12-04

    GE SIGNA and DISCOVERY PET/MR Scanners Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling SIGNA PET/MR and DISCOVERY PET/MR imaging systems because gradient coils can produce elevated acoustic noise during scanning under specific conditions.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0062-2025·2024-12-04

    Topical menthol back patch recalled for manufacturing deviations

    ABSORBINE jr. Extra Large Back Patch containing 5% menthol is being recalled nationwide due to manufacturing compliance deviations. The Class II recall affects 6,848,820 patches distributed by Absorbine Jr., LLC.

    Product
    ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2025·2024-12-04

    Z-800WF Infusion Pumps Recalled for Software Incompatibility Issue

    Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.

    Product
    Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certi
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0071-2025·2024-12-04

    FDA Recalls Cheeky Bonsai Menthol Pain Relief Patches for Manufacturing Deviations

    Cheeky Bonsai Pain Relief Patches (Menthol 10%) are being recalled nationwide due to manufacturing facility compliance deviations. The voluntary recall affects 17,928 patches distributed across the US.

    Product
    CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0059-2025·2024-11-27

    Calcium Antacid (Calcium Carbonate) Recall Due to Blister Packaging Separation

    Safecor Health recalls 791 boxes of Calcium Carbonate chewable tablets (Lot 24A0073) due to cGMP deviations where blister card-foils separated from blister cavities.

    Product
    CALCIUM ANTACID — CALCIUM ANTACID (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0056-2025·2024-11-27

    Vitamin D3 Dietary Supplement Recalled for Packaging Defect

    Safecor Health is recalling specific lots of Vitamin D3 25 mcg tablets due to a manufacturing defect where blister card-foils may separate from the blister cavity. No illnesses or injuries have been reported.

    Product
    Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
    Category
    Drug
    Distribution
    Distributed nationwide