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.

13551–13575 of 21617

  • ModerateFDA (Devices)·Z-0643-2017·2016-11-30

    Synthes Recalls 2.5 mm Calibrated Reaming Rods Due to Pouch Delamination

    Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.

    Product
    2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1045-2017·2016-11-30

    West-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure

    West-Ward Pharmaceuticals is recalling specific lots of Phenobarbital Tablets because they failed to meet dissolution specifications at the 12-month stability time point.

    Product
    PHENOBARBITAL — PHENOBARBITAL (PHENOBARBITAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2017·2016-11-30

    Actavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets

    Actavis Elizabeth LLC is recalling Nifedipine Capsules USP, 10 mg, because the product may contain foreign tablets or capsules.

    Product
    NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0482-2017·2016-11-30

    Infiniti Creations Recalls Simeons Program HCG Drops for Misbranding

    Infiniti Creations, LLC is voluntarily recalling Simeons Program HCG Drops due to misbranding and potential undeclared HCG content.

    Product
    Simeons Program. 2oz HCG Drops. Amber Plastic.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0636-2017·2016-11-30

    Pentax Video Colonoscope Recall for Missing Operation and Reprocessing Instructions

    Pentax of America is recalling video colonoscopes shipped between April 2014 and September 2015 because they included outdated instruction manuals and lacked required reprocessing adaptors.

    Product
    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2017·2016-11-30

    AHP Nifedipine Capsules Recalled for Presence of Foreign Tablets

    Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg, due to the presence of foreign tablets or capsules in the packaging.

    Product
    AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0649-2017·2016-11-30

    Merit Medical Recalls Fluid Administration Sets Due to Molding Defect

    Merit Medical Systems is voluntarily recalling 107,341 Fluid Administration Sets due to a molding defect in the drip chamber.

    Product
    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0640-2017·2016-11-30

    Synthes 3.0 mm Guide Rods Recalled for Delaminating Peel Pouches

    Synthes (USA) Products LLC is recalling 319 sterile 3.0 mm Guide Rods because their peel pouches are delaminating.

    Product
    3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0625-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 14 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0628-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Oversized Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0641-2017·2016-11-30

    Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.

    Product
    2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0483-2017·2016-11-30

    Infiniti Creations Recalls HCG Plus Drops Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Plus drops due to misbranding and potential undeclared HCG content.

    Product
    HCG Plus. 2oz HCG Drops. Blue Glass
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0455-2017·2016-11-23

    Simply Balanced White Chicken Chili Dry Soup Mix Recalled for Metal Shavings

    Conifer Specialties, Inc. is recalling Simply Balanced White Chicken Chili dry soup mix due to contamination with metal shavings. The product is a dry mix and does not contain chicken.

    Product
    Simply Balanced brand White Chicken Chili dry soup mix. This is not a ready to eat product and it does not contain any chicken. It is packaged in a clear poly bag with print on front and back, Net WT. 10 oz.., UPC is 0 85239 18973 3.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0607-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.

    Product
    SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2017·2016-11-23

    Bard Inlay Optima Ureteral Stent Recalled for Labeling Update

    C.R. Bard is recalling 75,089 Bard Inlay Optima ureteral stents to add a warning about potential knots during removal.

    Product
    Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide