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.

6726–6750 of 21595

  • ModerateFDA (Drugs)·D-1376-2020·2020-07-08

    Flexion Recalls Zilretta Injectable Suspension Due to Temperature Abuse

    Flexion Therapeutics is recalling 792 kits of Zilretta (triamcinolone acetonide) because the product was stored at room temperature for more than six weeks.

    Product
    Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2020·2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall affects 104 packages distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2483-2020·2020-07-08

    Ortho VITROS 5600 System Recall for Software Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.

    Product
    VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2434-2020·2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a manufacturing error resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2466-2020·2020-07-08

    ROi CPS LLC Recalls Respirator Crash Cart Kits Due to Labeling Error

    ROi CPS LLC is recalling 200 Respirator Crash Cart Kits because the kits are labeled with an expiration date later than the soonest component to expire.

    Product
    Respirator Crash Cart Kit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2478-2020·2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall involves 147 kits distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2484-2020·2020-07-08

    Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2486-2020·2020-07-08

    Ethicon Recalls Silk Sutures Due to Potential Shelf Life Deficiency

    Ethicon, Inc. is recalling specific lots of PERMA-HAND/MERSILK and VIRGIN SILK Blue twisted Silk Sutures because they may not meet the required 5-year shelf life.

    Product
    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2435-2020·2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1361-2020·2020-07-08

    Children's Robitussin DM Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling 132,336 bottles of Children's Robitussin DM because the included dosing cups lack age-specific measurement markings.

    Product
    CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM — CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2020·2020-07-08

    Ortho VITROS 5600 Software Recall for Parameter Reset Defect

    Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.

    Product
    VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2480-2020·2020-07-08

    Ortho VITROS 3600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2020·2020-07-08

    Ortho VITROS 3600 System Recalled for Assay Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test results.

    Product
    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2020·2020-07-08

    ROi CPS Recalls Isolation Droplet Bundle Kits Due to Labeling Error

    ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits because the kits are labeled with an expiration date later than the expiration date of the soonest component.

    Product
    Isolation Droplet Bundle Kit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2436-2020·2020-07-08

    Westmed Neo-Vent Infant T-Piece Resuscitation Circuit Recall for Non-Compliant Connections

    Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1362-2020·2020-07-08

    Children's Dimetapp Cold & Cough Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling Children's Dimetapp Cold & Cough bottles because the included dosing cups are missing graduation marks for certain age groups.

    Product
    Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-1341-2020·2020-07-01

    Alembic Recalls Aripiprazole Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1335-2020·2020-07-01

    QuVa Pharma Recalls R.E.C.K. Syringes Due to Particulate Matter

    QuVa Pharma is recalling 17,050 syringes of R.E.C.K. solution because they may contain particulate matter. The product was distributed nationwide in the US.

    Product
    R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1337-2020·2020-07-01

    Soft Whisper Dandruff Shampoo Recalled for Water Quality Deviations

    A.P. Deauville, LLC is recalling Soft Whisper Dandruff Shampoo because it was produced with water that failed USP specifications.

    Product
    Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2020·2020-07-01

    Siemens RP500e Handheld Barcode Scanner Recalled for Data Integrity Failure

    Siemens Healthcare Diagnostics Inc. is recalling 436 RP500e Handheld Barcode Scanners because they fail to verify Code 39 barcode data integrity using check-digits.

    Product
    RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
    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