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.

9151–9175 of 21595

  • ModerateFDA (Food)·F-1306-2019·2019-05-01

    Samira Food Products Soy Chunk Recalled for Undeclared Sulfites

    Traders West Inc is recalling Samira Food Products Vegeterian 100% Soy Chunk due to failure to declare sulfites.

    Product
    Samira Food Products Vegeterian 100% Soy Chunk, Net Wt. 8oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1208-2019·2019-05-01

    Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement

    Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.

    Product
    Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2019·2019-04-24

    Ethicon Recalls VICRYL Sutures Due to Labeling Mismatch

    Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1301-2019·2019-04-24

    ConAgra Recalls Hunts Tomato Paste Cans Due to Potential Mold

    ConAgra Foods is recalling 145,380 cans of Hunts Tomato Paste No Salt Added due to potential mold caused by can damage.

    Product
    Hunts Tomato Paste No Salt Added 6 ounce cans, 12 per wholesale tray Can UPC: 2700038807 Tray UPC: 2700038809
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1295-2019·2019-04-24

    Cays LLC Recalls Addback Tablets Due to Undeclared Coating Ingredients

    Cays LLC is recalling 2,095 bottles of Addback Tablets because the product contains undeclared coating ingredients and lists an ingredient not in the formulation.

    Product
    Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm name Prevent D Labs Division of CAYS, LLC Southington, CT
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1171-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-1293-2019·2019-04-24

    Wholesome Treats Recalls Breads from Anna Dairy and Corn Free Bread Mix

    Wholesome Treats, Inc. is recalling Breads from Anna Dairy & Corn Free Bread Mix because the product contains undeclared flaxseed.

    Product
    Breads from Anna Dairy & Corn Free Bread Mix 19oz, carton
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2019·2019-04-24

    Philips Medical Systems Recalls Foot Switches for Imaging Systems

    Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent live fluoroscopy images or exposures.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2019·2019-04-24

    Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays due to incorrect metallic coating material symbols on labels and instructions.

    Product
    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1141-2019·2019-04-24

    Philips Medical Systems Recalls Foot Switches for Allura Xper Systems

    Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.

    Product
    Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2019·2019-04-24

    Integra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle implants because the labels list an incorrect metallic coating material symbol.

    Product
    Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Drugs)·D-1123-2019·2019-04-24

    InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter

    InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because they contain particulate matter.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1124-2019·2019-04-24

    InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter

    InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because of the presence of particulate matter. The affected vials were distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1166-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1135-2019·2019-04-24

    Ethicon Recalls VICRYL Plus Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1175-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1144-2019·2019-04-24

    Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure

    Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.

    Product
    Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equip
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1194-2019·2019-04-24

    Roche Albumin BCP Reagent Recalled for Calibration Failures and QC Imprecision

    Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.

    Product
    Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2019·2019-04-24

    Philips Brilliance 64 CT Systems Recalled for Image Artifacts

    Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.

    Product
    Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1165-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1173-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1142-2019·2019-04-24

    Philips Brilliance 16 Air CT Systems Recalled for Collimator Defect

    Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.

    Product
    Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display eq
    Category
    Medical Device
    Distribution
    0 states