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.

2376–2400 of 21589

  • ModerateFDA (Devices)·Z-0500-2025·2024-11-27

    Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues

    NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.

    Product
    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PREC
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0498-2025·2024-11-27

    Olympus Gastrointestinal Videoscope Drying Instructions Clarified

    Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.

    Product
    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0058-2025·2024-11-27

    Aspirin 81 mg chewable tablets recalled due to packaging defect

    Safecor Health, LLC is recalling 1,470 boxes of Aspirin 81 mg chewable tablets nationwide due to a manufacturing defect where blister card-foils are separating from the blister cavity.

    Product
    ASPIRIN — ASPIRIN (ASPIRIN 81 MG)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0139-2025·2024-11-27

    Dietary Supplement Recalled: Douglas Labs Stress-B-Plus Due to Niacin Form Mismatch

    Nestle Health Science is recalling Douglas Labs Stress-B-Plus Dietary Supplement due to incorrect formulation. The product contains Niacin as Nicotinic acid but the label states Niacinamide.

    Product
    Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944 and 50344396. Expiration Date 04/11/2026
    Category
    Drug
    Distribution
    35 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
  • 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 (Food)·F-0123-2025·2024-11-20

    Berkeley Springs Water Recalled for Coliform Contamination

    Berkeley Club Beverages is recalling Berkeley Springs Water Purified and Distilled due to coliform contamination detected during testing. The recall affects 1,304 bottles distributed in West Virginia, Maryland, and Virginia.

    Product
    Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,090426,090526,090626.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0043-2025·2024-11-20

    Lanthanum Carbonate 1000mg Chewable Tablets Recalled for Broken and Crushed Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2025·2024-11-20

    Philips Zenition 70 Recall Due to Potential Fuse Failure

    Philips is recalling Zenition 70 devices because the mains control unit board fuse may blow during start-up or procedures.

    Product
    Philips Zenition 70, Model Number: 718133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0459-2025·2024-11-20

    Getinge MEERA CL Mobile Operating Table Recalled for Intermittent Movement Errors

    Getinge is recalling 52 MEERA CL mobile operating tables because an error code may cause the table to stop moving, potentially delaying surgical procedures.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0045-2025·2024-11-20

    Hydralazine Tablets Recalled Due to Failed Impurities and Degradation Testing

    Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.

    Product
    Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0350-2025·2024-11-20

    Medline arthroscopy surgical kits recalled for incomplete packaging seal

    Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.

    Product
    ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0363-2025·2024-11-20

    Karl Storz Irrigation Tubing Recalled for Unapproved Label Use

    Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.

    Product
    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2025·2024-11-20

    Perio Maintenance Rinse Recalled for Subpotent Stannous Fluoride Concentration

    Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.

    Product
    Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0457-2025·2024-11-20

    Getinge MEERA CL mobile operating table recalled for sporadic movement errors

    Getinge is recalling 234 MEERA CL mobile operating tables because an error code may cause the table to stop moving sporadically, potentially delaying surgical procedures.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2025·2024-11-20

    FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops

    Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2025·2024-11-13

    Dapsone Gel 7.5% recalled nationwide due to crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2025·2024-11-13

    Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy

    Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.

    Product
    MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0111-2025·2024-11-13

    MySyrup Sugar Free Almond Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Almond Syrup due to missing production records. The recall affects 212 jugs with batch numbers and expiration dates from August 2023 through December 2024.

    Product
    MySyrup Sugar Free Almond Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, Madagascar vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame pot
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0284-2025·2024-11-13

    Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction

    27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.

    Product
    Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-0116-2025·2024-11-13

    MySyrup Sugar Free Peppermint Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Peppermint Syrup (68 fl oz bottles) nationwide due to missing production records documenting the acidification process. No illnesses have been reported.

    Product
    MySyrup Sugar Free Peppermint Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassium, citric acid. Ma
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2025·2024-11-13

    Adult Cap-ONE Biteblock devices recalled for expired product distribution

    Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.

    Product
    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2025·2024-11-13

    Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure

    Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.

    Product
    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0119-2025·2024-11-13

    Oregon Orchards Banana Smoothie Mix recalled for inadequate acidification documentation

    My Chai Inc is recalling Oregon Orchards Banana Smoothie Mix nationwide due to insufficient production records proving proper acidification. Consumers should not consume the product.

    Product
    Oregon Orchards Banana Smoothie Mix. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Sugar, banana puree, water, natural flavor, citric acid, xanthan gum, sodium benzoate (to help protect flavor-1/10 of 1%), vanilla
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2025·2024-11-13

    Biocare Medical Recalls IHC Kits Due to Potential Staining Failure

    Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.

    Product
    intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer,
    Category
    Medical Device
    Distribution
    Distributed nationwide