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.

2076–2100 of 21710

  • ModerateFDA (Devices)·Z-2011-2025·2025-07-02

    Altivate Reverse Torx Peripheral Screw package labeling mismatch

    Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.

    Product
    Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·H-0060-2025·2025-07-02

    Madeline's Patisserie Butter Croissant Buns recalled for undeclared wheat

    Element 112, LLC is recalling Madeline's Patisserie 4.25 Inch Butter Croissant Buns because they contain undeclared wheat, a major food allergen.

    Product
    Madeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and packed in a food service case; 24 per case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2012-2025·2025-07-02

    Caphosol Artificial Saliva sachets recalled for out-of-specification stability

    Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.

    Product
    Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0094-2025·2025-07-02

    Probese Caps dietary supplement recalled for undeclared food dyes

    Probese Caps, a dietary supplement with Iron sold in 90-count bottles, is being recalled because it contains undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules.

    Product
    Probese Caps, dietary supplement with Iron. 90-count bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateNHTSA·25V417000·2025-06-27

    Bowlus trailer manual omits hitch bolt retightening from maintenance schedule

    Bowlus is recalling certain trailers with an elongated hitch because the owner's manual does not include instructions to retighten the two hitch bolts in the maintenance schedule.

    Product
    BOWLUS — BOWLUS ENDLESS HIGHWAYS, TERRA FIRMA, VOLTERRA, RIVET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0471-2025·2025-06-25

    Amazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration

    Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets due to confirmed consumer complaints of brown surface discoloration on tablets, a cGMP deviation.

    Product
    AMAZON BASIC CARE ACETAMINOPHEN — AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0051-2025·2025-06-25

    Pizza Shoppe Pink Stuff Creamy Garlic Salad Dressing Recalled for Potential Spoilage

    La Fontanella Food Products LLC is recalling Pizza Shoppe The "Pink Stuff" World-Famous Creamy Garlic Salad Dressing (12 oz bottles) due to detected increased lactic acid levels indicating potential product spoilage.

    Product
    Pizza Shoppe The "Pink Stuff" World-Famous Creamy Garlic Salad Dressing, net wt. 12oz, UPC 896537002019 packaged in clear plastic bottle with twist lid. Bottles are packed 6/case.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·H-0098-2025·2025-06-25

    CPK Tequila Lime Base Recalled for Possible Wood Contamination

    Bakkavor Foods USA, Inc. is recalling CPK Tequila Lime Base because the product may contain pieces of wood. The affected 1 lb bags were distributed to Alabama, California, Florida, and Maryland.

    Product
    CPK TEQUILA LIME BASE ALLERGENS: MILK NET WEIGHT: 1 LB Case UPC FG15453558 Manufactured for California Pizza Kitchen, Inc.***Los Angeles, CA
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1978-2025·2025-06-25

    MiniDock Integrated Nucleic Acid Testing Device Recall

    Guangzhou Pluslife Biotech is recalling the MiniDock Integrated Nucleic Acid Testing Device (Model PM001) because it was distributed in the U.S. without required FDA premarket authorization.

    Product
    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2025·2025-06-25

    Lago X X-ray instrument recall due to labeling discrepancies

    Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA requirements.

    Product
    Lago X
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0472-2025·2025-06-25

    Gentamicin Injection Pediatric Vials Recalled for Failed Stability Tests

    Eugia US LLC is recalling Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL due to failed color absorbance test results during 12-month stability analysis. The recall affects 48,000 vials distributed nationwide.

    Product
    GENTAMICIN — GENTAMICIN (GENTAMICIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1986-2025·2025-06-25

    Surgical Mesh Recalled Due to Residual Adhesive Material Concern

    Chamberlain Technologies LLC is recalling SURGIMESH WN polymeric surgical mesh due to potential residual adhesive material on the mesh surface. The recall affects 20 units distributed to Illinois, Nebraska, and California.

    Product
    SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1984-2025·2025-06-25

    Surgical Mesh Product Recalled Due to Residual Adhesive Material

    Chamberlain Technologies is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The product was distributed to facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1993-2025·2025-06-25

    STA-Owren Koller Buffer Solution Recall Due to Clotting Time Concerns

    Diagnostica Stago is recalling STA-Owren Koller buffer solution (Lot 270902) because it may produce shorter clotting times in certain tests, potentially leading to a 1% overestimate of clotting results.

    Product
    STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1983-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH WN Polymeric Surgical Mesh due to potential residual adhesive material on the mesh surface. The 60-unit recall affects medical facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1979-2025·2025-06-25

    Pluslife SARS-CoV-2 Card Test Kits Recalled for Lack of FDA Authorization

    Pluslife SARS-CoV-2 Card nucleic acid testing kits were distributed in the U.S. without required FDA premarket authorization. The FDA is recalling approximately 1,850 boxes distributed nationwide and internationally.

    Product
    Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0042-2025·2025-06-18

    Supreme Produce Apple & PB Snack Cup Recalled for Plastic

    GBC Food Services is recalling Supreme Produce Apple & PB Snack Cup due to possible plastic foreign material in the product. Affected units were distributed in GA, MI, IN, and TN with Best By dates from 4/12/2025 to 5/6/2025.

    Product
    Supreme Produce Apple & PB Snack Cup. Net Wt: 8oz (226g). Keep Refrigerated. UPC 8 50065-403 1. GBC Food Services, 14043 Distribution Way, Farmers Branch, Texas
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1926-2025·2025-06-18

    DxI 9000 Access Immunoassay Analyzer software version 1.20 recall

    Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2025·2025-06-18

    BD BBL CultureSwab EZ Collection and Transport System Swabs Breakage

    BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.

    Product
    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0015-2025·2025-06-18

    Comvita Manuka Honey Cordyceps recalled for faulty packaging seal

    Comvita Manuka Honey + Cordyceps is being recalled due to a leaking induction seal on the packaging. The defect affects approximately 2,730 units distributed across multiple states.

    Product
    Comvita branded Manuka Honey + Cordyceps for energy; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001037
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·H-0014-2025·2025-06-18

    Comvita Manuka Honey Lion's Mane product recall packaging defect

    Comvita Manuka Honey + Lion's Mane for Focus is recalled due to a leaking induction seal on the packaging. Approximately 2,730 units distributed across multiple U.S. states are affected.

    Product
    Comvita branded Manuka Honey + Lion's Mane for Focus; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001020
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·H-0016-2025·2025-06-18

    Comvita Manuka Honey + Reishi recalled for leaking induction seal

    Comvita Manuka Honey + Reishi is recalled due to a leaking induction seal on the packaging. The product may not be properly sealed.

    Product
    Comvita branded Manuka Honey + Reishi; made in New Zealand, Net Wt. 12 fl oz (355g); Barcode# 658196001013
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0469-2025·2025-06-18

    Cephalexin Oral Suspension Recalled for Failed Impurities Specifications

    Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2025·2025-06-18

    Baxter Novum IQ Syringe Pump Design Issue Recall

    Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.

    Product
    Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
    Category
    Medical Device
    Distribution
    Distributed nationwide