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.

2401–2425 of 21589

  • 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
  • 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-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
  • ModerateNHTSA·24V852000·2024-11-08

    Air Bag Warning Label Missing on Ford and Lincoln Vehicles

    Ford is recalling certain 2018-2025 Ford and Lincoln vehicles for missing air bag warning labels on the dashboard. The missing label increases risk of crash injury if occupants don't follow proper restraint guidelines.

    Product
    FORD — FORD, LINCOLN EXPLORER, CORSAIR, AVIATOR, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0070-2025·2024-11-06

    International Delight Peppermint Mocha Mislabeled as Zero Sugar Product Recall

    DANONE US LLC is recalling Home Alone International Delight Peppermint Mocha Zero Sugar beverages because the product is labeled as zero sugar but actually contains sugar. The recall affects 1,799 cases distributed across multiple states.

    Product
    Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0260-2025·2024-11-06

    Surgical tracking device patient labels show incorrect expiration date

    Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

    Product
    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0271-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption

    King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.

    Product
    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation

    King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2025·2024-11-06

    West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk

    West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.

    Product
    Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the rec
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-0276-2025·2024-11-06

    KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use

    King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0258-2025·2024-11-06

    17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy

    DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.

    Product
    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
    Category
    Medical Device
    Distribution
    3 states
  • ModerateCPSC·25026·2024-10-31

    Humane Charge Case Accessory for Ai Pin Recalled for Lithium Battery Fire Hazard

    Humane Inc. is recalling about 10,500 Charge Case Accessory units for the Ai Pin because the lithium battery can overheat and pose a fire hazard. The company has received one report of a charge case overheating and melting during charging, though no injuries or property damage have been reported.

    Product
    Humane Charge Case Accessory for Ai Pin
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2025·2024-10-30

    Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0018-2025·2024-10-30

    Vancomycin Injection Recalled Due to Manufacturing Process Violations

    Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.

    Product
    Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0064-2025·2024-10-30

    Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage

    Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.

    Product
    Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0166-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Class II Recall

    Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2025·2024-10-30

    Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming

    Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.

    Product
    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2025·2024-10-30

    Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations

    Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.

    Product
    OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0021-2025·2024-10-30

    Oxytocin Injection Recalled for Current Good Manufacturing Practice Violations

    Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.

    Product
    Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2025·2024-10-30

    Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns

    Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.

    Product
    smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0207-2025·2024-10-30

    Diasol Acid Concentrate Recalled for Labeling Discrepancy

    Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.

    Product
    Diasol Acid Concentrate REF G100325-10Dex 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2025·2024-10-30

    Drug injection product recalled due to manufacturing quality violations

    Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2025·2024-10-30

    Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance

    Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.

    Product
    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2025·2024-10-30

    Sterile drug injection bags recalled for manufacturing process violations

    Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0138-2025·2024-10-30

    Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.

    Product
    Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide