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.

9226–9250 of 21595

  • ModerateFDA (Food)·F-1244-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 2,400 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A29322 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1091-2019·2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1084-2019·2019-04-17

    X-Gen Recalls Clonidine Injection Vials Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCL Injection vials because the side carton incorrectly lists the concentration as 500 mcg instead of 100 mcg per mL.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2019·2019-04-17

    Becton Dickinson Recalls Gravity IV Sets Due to Kinked Tubing

    Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.

    Product
    Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1118-2019·2019-04-17

    Arrow Two-Lumen Central Venous Catheterization Kit Recalled for Labeling Error

    Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.

    Product
    Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1243-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 20,000 lbs of commercial breader batter that may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A28986 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1124-2019·2019-04-17

    Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues

    Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1103-2019·2019-04-17

    FDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions

    Professional Compounding Pharmacy is recalling compounded Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during a recent FDA inspection.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1262-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 20,150 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; #22419 BATTER MX X2; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1126-2019·2019-04-17

    Ulrich Torque Limiting Handles Recalled for Exceeding Calibration Life

    Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles because they are beyond their 3-year calibration life.

    Product
    ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1111-2019·2019-04-17

    Beaver Xstar Slit Knife Recalled for Size Mismatch Labeling

    Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.

    Product
    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1090-2019·2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1248-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 40,250 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A81225 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1125-2019·2019-04-17

    Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over

    Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1255-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 32,900 lbs of commercial breader batter that may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A96289 BREADER X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1113-2019·2019-04-17

    Gavilyte-N Recalled for Incorrect Flavor Labeling on Orange and Cherry Packets

    Lupin Somerset is recalling Gavilyte-N because orange and cherry flavor packets incorrectly list 'natural lemon flavor' as an ingredient.

    Product
    GAVILYTE-N — GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1131-2019·2019-04-17

    Lohxa Recalls Phenobarbital Oral Solution Due to Incorrect Expiration Date

    Lohxa LLC is recalling Phenobarbital Oral Solution because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.

    Product
    Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
    Category
    Drug
    Distribution
    3 states