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.

6751–6775 of 21595

  • ModerateFDA (Devices)·Z-2420-2020·2020-07-01

    Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2419-2020·2020-07-01

    Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1338-2020·2020-07-01

    Crown Laboratories Recalls Subpotent Nystatin Cream Tubes

    Crown Laboratories is recalling 62,274 tubes of Nystatin Cream because the product failed potency testing at the 9-month interval.

    Product
    NYSTATIN CREAM — NYSTATIN CREAM (NYSTATIN CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2020·2020-07-01

    RayStation Software Recalled for Treatment Record Import and Display Issues

    RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.

    Product
    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2421-2020·2020-07-01

    Coltene Recalls Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2020·2020-07-01

    Siemens ADVIA Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lots 534177 and 534179 due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    ADVIA Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·014-2020·2020-06-28

    Pilgrim's Pride Recalls Chicken Breast Nuggets Due to Rubber Contamination

    Pilgrim's Pride is recalling approximately 59,800 pounds of fully cooked chicken breast nuggets that may contain flexible rubber material.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corporation Recalls Chicken Breast Nugget Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1324-2020·2020-06-24

    Gaviscon Extra Strength Liquid Antacid Recalled for Missing Magnesium Warning

    GSK is recalling Gaviscon Extra Strength Liquid Antacid because the bottle label is missing a required magnesium safety warning.

    Product
    Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1309-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect

    Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2020·2020-06-24

    Gaviscon Antacid Recalled for Missing Magnesium Safety Warning

    Gaviscon Regular Strength Liquid Antacid is being recalled because the bottle label lacks the required magnesium safety warning.

    Product
    GAVISCON — GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2020·2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective Saline Flush Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M036708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC kits because they contain BD saline flush syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the samplin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids. The product is used for in vitro diagnostic testing.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2020·2020-06-24

    Gaviscon Antacid Recalled for Missing Magnesium Safety Warning

    GSK is recalling Gaviscon Regular Strength Liquid Antacid bottles because the labels lack a required magnesium safety warning.

    Product
    GAVISCON — GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2395-2020·2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1308-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect

    Hikma Pharmaceuticals is recalling 82,426 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids compared to expected standards.

    Product
    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1325-2020·2020-06-24

    Gaviscon Liquid Antacid Recalled for Missing Magnesium Safety Warning

    Gaviscon Liquid Antacid Extra Strength is being recalled because the bottle label lacks a required magnesium safety warning. The recall covers single and twin-pack bottles distributed nationwide.

    Product
    GAVISCON — GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects

    Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1310-2020·2020-06-24

    EcoLips Sport Lip Balm Recalled for Excessive Avobenzone Concentration

    Eco Lips Inc. is recalling 68,400 tubes of EcoLips Sport Lip Balm, SPF 30, because the avobenzone concentration exceeds FDA limits.

    Product
    EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2020·2020-06-24

    Diasol Recalls Liquid Acid Concentrate for Hemodialysis Due to Labeling Error

    Diasol, Inc. is recalling 212 cases of liquid acid concentrate for hemodialysis because of incorrect labeling of the dialysate concentration.

    Product
    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2280-2020·2020-06-17

    Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference

    Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.

    Product
    ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide