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.

5976–6000 of 21595

  • ModerateFDA (Drugs)·D-0327-2021·2021-04-14

    Cosette Recalls Mometasone Furoate Topical Solution Due to CGMP Deviations

    Cosette Pharmaceuticals is recalling specific lots of Mometasone Furoate Topical Solution due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0433-2021·2021-04-14

    Toasted Oat Apricot Shortbread Granola Recalled for Mold Contamination

    The Toasted Oat is recalling Apricot Shortbread Soft Granola because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Apricot Shortbread Soft Granola (6 - 10oz pouches per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0323-2021·2021-04-14

    Washington Homeopathic Products Recalls LCL-2-0191 Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling LCL-2-0191 because it was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1351-2021·2021-04-14

    Nuvasive Freedom End Caps Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics Inc. is recalling 59 units of Freedom End Caps and related components because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1359-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1364-2021·2021-04-14

    Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization

    Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.

    Product
    Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0432-2021·2021-04-14

    Toasted Oat Cherry Streusel Granola Recalled for Mold-Containing Ingredient

    The Toasted Oat is recalling Cherry Streusel Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Cherry Streusel Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Cherry Streusel ( 5 - 28.3g bars per pack/6 packs per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1350-2021·2021-04-14

    Nuvasive Precice Unyte Orthopedic Rods Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics is recalling Precice Unyte orthopedic trauma nails because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic traum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2021·2021-04-14

    Integra LifeSciences Recalls CODMAN HAKIM BACTISEAL Shunt Catheters Due to Labeling Error

    Integra LifeSciences is recalling 49 units of CODMAN HAKIM BACTISEAL Shunt System catheters because they lacked required drainage holes and markings.

    Product
    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1353-2021·2021-04-14

    Gf Health Products Recalls Drop Arm Versamode Due to Incorrect Casters

    Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.

    Product
    Drop Arm Versamode"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0424-2021·2021-04-14

    Babco Foods Recalls Anand Far Far Garlic Sandige for Undeclared Yellow 6

    Babco Foods International is recalling Anand Far Far (Garlic Sandige) because it contains undeclared Yellow 6, a food dye.

    Product
    Anand Far Far (Garlic Sandige) Net Weight 7 oz./200 g package ingredients: rice, wheat flour, garlic, red chilli, refined palm oil and salt. UPC 8 78776 00232 6 Product of India Imported and Distributed by Babco Foods International, LLC, Bridgewater, NJ
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1357-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set

    Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0392-2021·2021-04-14

    Horizon Nut Company Recalls Pistachios for Pesticide Residue

    Horizon Nut Company is recalling roasted salted in-shell pistachios because they may contain low levels of the pesticide imidacloprid above the legal limit.

    Product
    Roasted Salted In shell Pistachios 3 lb. bag, 25 lb cartons, 30 lb. cartons, 50 lb. sacks, 2,000 lb. sacks, 2,200 lb sacks Packed by horizon Nut Company Tulare, CA 93274 Product of U.S.A.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0319-2021·2021-04-14

    Kimberly-Clark Recalls Scott Moisturizing Foam Hand Sanitizer Due to Labeling Error

    Kimberly-Clark is recalling Scott Moisturizing Foam Hand Sanitizer because some bottles containing Foam Skin Cleanser soap are incorrectly labeled as hand sanitizer.

    Product
    Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0431-2021·2021-04-14

    Toasted Oat Macadamia Chunk Granola Recalled for Mold-Containing Ingredient

    The Toasted Oat is recalling Macadamia Chunk Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Macadamia Chunk Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Macadamia Chunk ( 5 - 28.3g bars per pack/6 packs per case).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1336-2021·2021-04-14

    Medtronic HVAD Controller Recall for Potential Port Damage

    Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1355-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits

    Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1316-2021·2021-04-07

    DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging

    DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.

    Product
    The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1315-2021·2021-04-07

    DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage

    DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.

    Product
    The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1314-2021·2021-04-07

    DePuy ATTUNE Knee Implant Recall for Damaged Packaging

    DePuy Orthopaedics is recalling ATTUNE and MBT tibial base components used in knee replacements due to potential damaged packaging.

    Product
    ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1327-2021·2021-04-07

    Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance

    Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.

    Product
    Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1326-2021·2021-04-07

    Philips SureSigns Patient Monitors Recalled for Pediatric Heart Rate Accuracy Issues

    Philips is recalling SureSigns VM4, VM6, and VM8 patient monitors in China because they fail to meet Chinese standards for heart rate accuracy in pediatric mode.

    Product
    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1329-2021·2021-04-07

    Oscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal

    Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F due to a potential open seal on the sterile product.

    Product
    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2021·2021-04-07

    LumiraDx Coronavirus Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling 2,186 coronavirus antigen test strips because two lots failed quality control testing and produced false positives.

    Product
    Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twel
    Category
    Medical Device
    Distribution
    Distributed nationwide