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.

6876–6900 of 21595

  • ModerateFDA (Devices)·Z-2052-2020·2020-05-27

    W L Gore Recalls 15 Thoracic Stent Grafts Due to Labeling Error

    W L Gore & Associates is recalling 15 Conformable Thoracic Stent Grafts distributed in Japan because incorrect labels were placed on the primary and secondary packaging.

    Product
    Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2078-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

    Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2064-2020·2020-05-27

    Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags

    Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.

    Product
    HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

    Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
    Category
    Medical Device
    Distribution
    4 states
  • ModerateCPSC·20127·2020-05-27

    Primark Recalls Kitten Heel Court Shoes Due to Chromium Levels

    Primark is recalling Wide Fit Kitten Heel Court Pumps because the leather insoles contain elevated levels of Chromium VI, posing a risk of skin irritation.

    Product
    Wide Fit Kitten Heel Court Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0956-2020·2020-05-27

    Frito-Lay Recalls Ruffles Onion Dip Jars Due to Mold Contamination Risk

    Frito-Lay is recalling Ruffles Onion flavoured dip jars in the US and Canada due to potential mold contamination.

    Product
    Ruffles Onion flavoured dip 425 g (15 oz). UPC 6041007298 packaged in clear glass jars
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0957-2020·2020-05-27

    Frito-Lay Recalls Ruffles Ranch Dip Jars Due to Potential Mold Contamination

    Frito-Lay is recalling Ruffles Ranch flavoured dip in 425 g glass jars sold in the US and Canada due to potential mold contamination.

    Product
    Ruffles Ranch flavoured dip 425 g (15 oz). UPC 6041007299 packaged in clear glass jars
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2067-2020·2020-05-27

    DFINE Vertebral Hydraulic Assemblies Recalled for Incorrect Expiration Dates

    Merit Medical Systems is recalling 228 DFINE Vertebral Hydraulic Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2066-2020·2020-05-27

    Baxter Recalls Prismaflex Control Units Lacking FDA Clearance

    Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.

    Product
    Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2097-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2073-2020·2020-05-27

    Capso Vision Recalls CapsoCam Plus Capsule Endoscopy Systems Due to Labeling Errors

    Capso Vision, Inc. is recalling 44 CapsoCam Plus video capsule systems because incorrect serial number labels may lead to patient misdiagnosis.

    Product
    CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-1271-2020·2020-05-27

    Mylan Recalls Aloprim Injection Vials Due to Discoloration

    Mylan Institutional LLC is recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection due to out-of-specification appearance and color results.

    Product
    ALOPRIM — ALOPRIM (ALLOPURINOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2093-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may detach from its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-1282-2020·2020-05-27

    West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures

    West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.

    Product
    Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2020·2020-05-27

    Boston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error

    Boston Scientific is recalling five AMS 700 100 mL Spherical Reservoirs with InhibiZone because they were incorrectly labeled as a different model.

    Product
    AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post within the inner packaging, resulting in loose devices and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2068-2020·2020-05-27

    Merit Medical Recalls DFINE Vertebral Assemblies Due to Incorrect Expiration Dates

    Merit Medical Systems is recalling 63 DFINE Vertebral Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fract
    Category
    Medical Device
    Distribution
    Distributed nationwide