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.

6701–6725 of 21595

  • ModerateFDA (Food)·F-1045-2020·2020-07-22

    Lamb Weston Recalls WinCo Tater Bites Due to Foreign Material Contamination

    Lamb Weston is recalling WinCo Foods Tater Bites Shaped, Shredded Potatoes because the product may contain foreign material. The recall covers 558 cases distributed in California, Oregon, and Washington.

    Product
    WinCo Foods Tater Bites Shaped, Shredded Potatoes, frozen product. Retail 32 oz. poly bag has UPC 0 70552 30303 4. The master case contains 12/32 oz. bags (net wt. 24 lbs.), identified as WinCo Foods Tater Bites WN420, 1 00 70552 30303 1. The 32 oz. retail package label is
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2639-2020·2020-07-22

    Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging

    Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.

    Product
    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1390-2020·2020-07-22

    Preferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records

    Preferred Pharmaceuticals is recalling Lidothol Patches because the contract manufacturer misplaced or lost batch records and test results.

    Product
    Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2020·2020-07-22

    Akorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, 0.5%, due to chemical contamination from equipment cleaning residue.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2637-2020·2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units distributed nationwide.

    Product
    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2525-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.

    Product
    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2020·2020-07-15

    Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.

    Product
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2539-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2512-2020·2020-07-15

    Medtronic Serena CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 17,750 Serena CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2543-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled for Oversized O-Ring Defect

    Cardinal Health is recalling 3,000 NPWT Canisters with Gel 300cc because they may contain an oversized O-ring that cannot be installed.

    Product
    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2505-2020·2020-07-15

    Medtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension

    Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.

    Product
    CareLink SmartSync Device Manager, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2513-2020·2020-07-15

    Medtronic Solara CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 16,667 Solara CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2540-2020·2020-07-15

    FHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect

    FHC, Inc. is recalling six Guideline 4000 5.0 Main Processing Units because an electrical sub-circuit was not properly connected, potentially affecting performance during ESD events.

    Product
    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2506-2020·2020-07-15

    Medtronic Patient Connector Recall for Temporary Feature Suspension

    Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.

    Product
    Patient Connector, Model Number 24967
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2536-2020·2020-07-15

    Capso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure

    Capso Vision is recalling 82 CapsoCam Plus capsules because they fail to record data when ingested, potentially delaying diagnosis.

    Product
    The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2508-2020·2020-07-15

    Medtronic Azure S DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.

    Product
    Azure S DR MRI, Model Number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2538-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2511-2020·2020-07-15

    Medtronic Percepta CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 37,360 Percepta CRT-P MRI devices due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2020·2020-07-15

    Teleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation

    Teleflex is voluntarily recalling 6,014 RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges when exposed to moisture.

    Product
    RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2510-2020·2020-07-15

    Medtronic Azure S SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure S SR MRI, Model Number W3SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2496-2020·2020-07-15

    Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error

    Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.

    Product
    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement T
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2535-2020·2020-07-15

    Laborie Pump Tube Sets Recalled for Damaged Packaging Seals

    Laborie Medical Technologies is recalling 480 Pump Tube Sets due to damaged packaging seals that may compromise product integrity.

    Product
    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2507-2020·2020-07-15

    Medtronic Azure XT DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2498-2020·2020-07-15

    CooperSurgical Recalls Mislabeled Os Finder Cervical Dilators

    CooperSurgical is recalling 2,250 Os Finder Cervical Dilators due to mislabeled blister trays. The product inside is correct, but the packaging label is incorrect.

    Product
    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
    Category
    Medical Device
    Distribution
    Distributed nationwide