The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

51–75 of 261

  • LowFDA (Devices)·Z-0500-2026·2025-11-19

    VerifyNow PRUTest Platelet Reactivity Test recalled without FDA premarket clearance

    Accriva Diagnostics is recalling VerifyNow PRUTest platelet reactivity tests because they were incorrectly packaged and distributed without required FDA premarket clearance. The recall involves 125 boxes (3,125 tests) distributed across U.S. states and internationally.

    Product
    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0313-2026·2025-11-12

    Osstem Dental X-Ray Systems Recalled for Missing Regulatory Certification Statement

    OSSTEM Implant Co., Ltd. is voluntarily correcting labeling for Osstem Dental X-Ray System T1 models T1-C and T1-CS because their labels may be missing a required FDA certification statement confirming compliance with radiological health standards.

    Product
    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0138-2026·2025-11-05

    FDA Recalls Espumil Lipophilic Foam Base for Labeling Issue

    Letco Medical LLC recalls Espumil Lipophilic foam base (batch 24G15-T02-115604) distributed to compounding pharmacies due to a labeling issue. The recall affects 173 bottles of 500 ml.

    Product
    Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0397-2026·2025-11-05

    DAYE Refill 3 Month Bundle Recalled for Lack of FDA Clearance

    DAYE's Refill 3 Month Regular Flow Bundle was distributed nationwide without FDA 510(k) premarket clearance. The Class II medical device was recalled because it was sold without the required regulatory approval.

    Product
    Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0226-2026·2025-10-29

    One Step Sterile Lancet Recalled Due to Missing or Incorrect UDI Codes

    Home Health US is recalling One Step Sterile Lancets due to missing or incorrect UDI codes on product labeling. Approximately 4,661 units were distributed nationwide through Amazon.

    Product
    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Food)·H-0641-2025·2025-10-08

    Frozen Whiting Fillets Recalled for Incorrect Best-By Date Label

    Stanley Pearlman Enterprises is recalling NAFCO frozen whiting fillets due to incorrect best-by dates printed on packaging. The packages show January 11, 2025, but products are actually good until January 11, 2027.

    Product
    NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact retail bag. 15 bags per case. Keep Frozen
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·H-0590-2025·2025-09-24

    Hi-Tech Pharmaceuticals Joint-RX Supplement Recalled for Unapproved Drug Claims

    Hi-Tech Pharmaceuticals is recalling Joint-RX dietary supplement (90 count) for making unapproved drug claims on labeling. The product was distributed nationwide; consumers should discontinue use and discard or return it.

    Product
    HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4 Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Dr Norcross, GA 30071
    Category
    Consumer Product
    Distribution
    50 states
  • LowFDA (Food)·H-0596-2025·2025-09-24

    LGSciences Dietary Supplement Recalled for Unapproved Drug Claims

    LGSciences Battle Hardener Platinum Series dietary supplement is being recalled due to unapproved drug claims. The product, containing 17-proandro and pBOLD Form-XT, was distributed nationwide.

    Product
    LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA 30071
    Category
    Drug
    Distribution
    50 states
  • LowFDA (Food)·H-0589-2025·2025-09-24

    Fish Oil Supplement Recalled for Unapproved Drug Claims

    Hi-Tech Pharmaceuticals fish oil supplement (85,950 units, Lot 517120551) is recalled for making unapproved drug claims on its label regarding cardiovascular health, joint pain, and cognitive function.

    Product
    HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Drug
    Distribution
    50 states
  • LowFDA (Food)·H-0591-2025·2025-09-24

    L-Glutamine dietary supplement recalled due to unapproved drug claims

    Hi-Tech Pharmaceuticals is recalling HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER because the product was marketed with unapproved drug claims. Consumers should stop using the product.

    Product
    HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE ELIMINATION LEAN MUSCLE 500 GRAMS NET WT. (17.630OZ) DIETARY SUPPLEMENT UPC 8 11836 02362 6 HI-TECH PHARMECEUTICALS, INC. 601
    Category
    Drug
    Distribution
    50 states
  • LowFDA (Food)·H-0594-2025·2025-09-24

    Dietary Supplement Quercetin Recalled for Unapproved Drug Claims

    Hi-Tech Pharmaceuticals is recalling Quercetin dietary supplements (Lot C1612) due to unapproved drug claims and misbranding.

    Product
    HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Drug
    Distribution
    50 states
  • LowFDA (Devices)·Z-2381-2025·2025-09-03

    Philips L8-4 Transducer Probe labeling clarification on useful life

    Philips Ultrasound is recalling 171,322 L8-4 Transducer Probes to provide clarification and labeling defining the useful life of the ultrasound transducers.

    Product
    L8-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2382-2025·2025-09-03

    Philips L9-3 Transducer Probe Labeling Clarification on Useful Life

    Recall issued to clarify and improve labeling defining the useful life of Philips L9-3 Transducer Probes. Manufacturer providing documentation clarification to healthcare providers nationwide.

    Product
    L9-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2358-2025·2025-09-03

    Philips C8-4v Transducer Probe Recalled for Useful Life Labeling Clarification

    Philips Ultrasound is recalling approximately 171,322 units of C8-4v Transducer Probes distributed nationwide to provide clarification and labeling defining the useful life of these ultrasound transducers.

    Product
    C8-4v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2354-2025·2025-09-03

    Philips C5-2 Lumify Transducer Probe labeling clarification on useful life

    Philips issues labeling clarification for the C5-2 Lumify Transducer Probe to define useful life of ultrasound transducers. The recall affects approximately 171,322 units distributed nationwide in the US.

    Product
    C5-2 Lumify Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2410-2025·2025-09-03

    X6-1 Transducer Probe labeling clarification on useful life definition

    Philips Ultrasound is issuing labeling clarification for approximately 171,322 X6-1 Transducer Probes distributed nationwide to define the useful life of these devices.

    Product
    X6-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2373-2025·2025-09-03

    Philips L12-4 Transducer Probe Recalled for Useful Life Labeling Clarification

    Philips Ultrasound is recalling 171,322 L12-4 Transducer Probes distributed nationwide to provide clarification and updated labeling regarding the useful life of the ultrasound transducers.

    Product
    L12-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2357-2025·2025-09-03

    Philips C8-4v Ultrasound Transducer Probe Labeling Clarification on Useful Life

    Philips Ultrasound is providing clarification and updated labeling to define the useful life of C8-4v transducer probes. This is a labeling update affecting approximately 171,322 units distributed nationwide.

    Product
    C8-4v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2362-2025·2025-09-03

    FDA Recalls Philips C9-3v Ultrasound Transducer Probe for Labeling Clarification

    FDA is recalling Philips C9-3v Transducer Probes to provide clarification and labeling regarding the useful life of the devices. Approximately 171,322 units were distributed throughout the United States.

    Product
    C9-3v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2405-2025·2025-09-03

    Philips Ultrasound VL13-5 Transducer Labeling Clarification

    Philips Ultrasound is clarifying labeling on 171,322 VL13-5 transducer probes distributed nationwide to better define the useful life of the equipment.

    Product
    VL13-5 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide