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.

326–350 of 21708

  • ModerateFDA (Devices)·Z-2838-2026·2026-08-12

    Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk

    Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.

    Product
    Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1223-2026·2026-08-12

    Pumpkin Tree Peter Rabbit Organics Banana and Strawberry Fruit Puree Recalled for Foreign Objects

    PT Organics Limited is recalling certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree pouches due to the potential presence of thin, soft plastic strands.

    Product
    Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree, 4oz/113g pouch, UPC 815367010780, PTO Item 10720. Distributed by: PT Organics Ltd, 333 South State St, Suite V-142, Lake Oswego, OR 97034. Product is pasteurized blend of banana and strawberry purees sold in…
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2867-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage

    Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2905-2026·2026-08-12

    COAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling

    The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0740-2026·2026-08-12

    Pediatric TPN Bags Recalled for Incorrect Formulation

    Central Admixture Pharmacy Services is recalling two patient-specific pediatric TPN bags due to incorrect product formulation. The recall affects lots 20-1535990-0-1 and 20-1535892-0-1 with an expiration date of July 16, 2026, distributed in Georgia only.

    Product
    Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844)…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2817-2026·2026-08-05

    Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues

    Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2026·2026-08-05

    Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues

    Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2816-2026·2026-08-05

    Medical Convenience Kits Recalled Due to Lidocaine Supplier Quality Issues

    Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was recalled for supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2026·2026-08-05

    AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues

    Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2026·2026-08-05

    Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue

    Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2814-2026·2026-08-05

    AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues

    Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0731-2026·2026-08-05

    Azelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture

    Glenmark Pharmaceuticals is recalling azelaic acid gel 15% after receiving complaints that the product felt grainy, gritty, or sandy. The nationwide recall covers specific lots with expiration dates from February through April 2028.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·26V506000·2026-08-04

    Wabash Recalls 2027 Van Trailers for Unlabeled ABS Indicator Light

    Wabash is recalling 2027 Van Trailers because the external ABS malfunction indicator light may lack a label, potentially confusing other drivers.

    Product
    WABASH — WABASH VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1177-2026·2026-07-29

    Vintage Roots Root Beer Syrup Recalled Due to Unapproved Sassafras Bark

    Vintage Roots LLC is recalling Vintage Roots Root Beer Syrup because it contains sassafras bark, which is an unapproved food additive.

    Product
    Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pure Cane Sugar, Sassafras Bark, Burdock Roots, Wild Cherry Bark, Molasses, Fresh…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2790-2026·2026-07-29

    Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination

    Medline Industries, LP is recalling specific Medline NEURO PACK convenience kits because they may contain low levels of Bacillus species contamination.

    Product
    Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0735-2026·2026-07-29

    Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure

    Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2026·2026-07-29

    Cyproheptadine Hydrochloride Syrup Recall Due to Precipitate

    Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.

    Product
    CYPROHEPTADINE HYDROCHLORIDE — CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2026·2026-07-29

    Olympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults

    Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.

    Product
    Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2773-2026·2026-07-29

    Pipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2026·2026-07-29

    FARASTAR PFA Generator and Cardiac Ablation Catheter Recalled Due to Labeling Discrepancy

    Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.

    Product
    FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2763-2026·2026-07-29

    Halyard EYE PACK Convenience Kits Recalled Due to Incorrect Betadine Concentration

    AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.

    Product
    Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2758-2026·2026-07-29

    Phantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches

    Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.

    Product
    P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-07292026-01·2026-07-29

    Red's Steak Cilantro Lime Burrito misbranded with undeclared egg allergen

    USDA FSIS issued a public health alert for Red's All Natural steak burritos that contain undeclared egg and were incorrectly labeled. The product was distributed to Costco locations in Illinois, Michigan, and Minnesota.

    Product
    RED'S ALL NATURAL, LLC. — FSIS Issues Public Health Alert for Steak Burrito Product Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states