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.

1251–1275 of 2769

LowFDA (Drugs)·D-0925-2017·2017-07-05
L. Perrigo Recalls Walgreens Cold and Flu Combo Packs Due to Label Error
L. Perrigo is recalling 1,998 Walgreens Daytime and Nighttime Cold & Flu combo packs in Illinois because the packaging sleeve incorrectly identifies the contents as Day-Night Cold and Flu instead of Day-Night Cough Liquid.
Product
Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0926-2017·2017-07-05
Gaviscon Chewable Tablets Recalled for High Magnesium Levels
Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.
Product
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Category
Drug
Distribution
Distributed nationwide
LowNHTSA·17V423000·2017-06-30
Yamaha Recalls 2017 YZFR3 Motorcycles for Incorrect Certification Label
Yamaha is recalling 2017 YZFR3 motorcycles because some may have Canadian certification labels instead of US labels, potentially obscuring safety recall information.
Product
YAMAHA — YAMAHA YZFR3
Category
Vehicle
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0910-2017·2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0907-2017·2017-06-21
Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 100.00 mL.
Product
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0911-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0920-2017·2017-06-21
Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures
Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0912-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error
Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2539-2017·2017-06-21
Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies
Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Category
Medical Device
Distribution
31 states
LowFDA (Drugs)·D-0906-2017·2017-06-21
Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.
Product
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2587-2017·2017-06-21
Teleflex Recalls Sheridan Intubating Stylets Due to Incorrect Size Labeling
Teleflex Medical is recalling Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets because the product size listed on the labeling is incorrect.
Product
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired sh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0909-2017·2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 192 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0913-2017·2017-06-21
Pharmedium Recalls IV Bags with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Drug
Distribution
Distributed nationwide
LowNHTSA·17V387000·2017-06-20
KZRV Recalls 2018 Recreational Trailers Due to Missing Certification Date
KZRV is recalling 2018 recreational trailers because the Federal Certification label lacks the manufacturing date, potentially preventing owners from identifying other safety recalls.
Product
KZRV — KZRV VENOM, SPORTSMEN SPORTSTER, SPREE, SPORT TREK
Category
Vehicle
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2309-2017·2017-06-14
Beekley Medical Mammography Skin Markers Recalled for Mislabeling
Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.
Product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2221-2017·2017-06-14
Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling
Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.
Product
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0897-2017·2017-06-14
Hetero USA Recalls Acyclovir Tablets Due to Human Hair Presence
Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.
Product
ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2316-2017·2017-06-14
MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.
Product
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green p
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2252-2017·2017-06-14
Argon Medical Recalls Arterial Access Needles Due to Packaging Defect
Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.
Product
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2200-2017·2017-06-07
Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling
Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.
Product
Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2213-2017·2017-06-07
Acumedia Nutrient Gelatin Recalled for Incorrect Expiration Date Labeling
Acumedia Manufacturers recalled 5 units of Nutrient Gelatin because the label displayed an incorrect expiration date.
Product
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2199-2017·2017-06-07
Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error
Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
Product
Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2212-2017·2017-06-07
Acumedia Sabouraud Dextrose Agar Recalled for Incorrect Storage Labeling
Acumedia is recalling 10 units of Sabouraud Dextrose Agar in Illinois due to incorrect storage temperature information on the label.
Product
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2203-2017·2017-06-07
Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling
Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.
Product
Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2169-2017·2017-06-07
Tosoh Bioscience Recalls AIA-PACK TgAb Control Set Due to Labeling Error
Tosoh Bioscience is recalling 64 boxes of AIA-PACK TgAb Control Set because the labels included instructions for a non-FDA approved methodology.
Product
AIA-PACK TgAb CONTROL SET
Category
Medical Device
Distribution
8 states