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.

11826–11850 of 21617

  • ModerateFDA (Devices)·Z-3209-2017·2017-10-04

    Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.

    Product
    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1178-2017·2017-10-04

    Teva Recalls Acarbose Tablets Due to Incorrect Expiration Date Labeling

    Teva Pharmaceuticals USA is recalling 3,275 bottles of Acarbose Tablets, 25 mg, because the product labeling displays an incorrect expiration date of July 2018 instead of the correct date of July 2017.

    Product
    Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3211-2017·2017-10-04

    Deerfield Imaging Recalls Starburst Adaptor Thumb Screws Due to Incorrect Thread

    Deerfield Imaging is recalling six Starburst adaptor thumb screws because they have incorrect threads. The affected units were distributed in Illinois, Oregon, and Pennsylvania.

    Product
    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3213-2017·2017-10-04

    Smiths Medical Recalls UniPerc Tracheostomy Tube Kits with Incorrect Obturator Size

    Smiths Medical is recalling 89 UniPerc tracheostomy tube kits because they contain a 9.0mm obturator instead of the correct 8.0mm size.

    Product
    UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tub
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3226-2017·2017-10-04

    Bard Magic 3 Antibacterial Catheters Recalled for Missing Coating

    C.R. Bard is recalling specific lots of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheters because they may lack the hydrophilic coating.

    Product
    Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-3215-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3217-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3214-2017·2017-10-04

    Ultradent Paper Points Recalled for Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.

    Product
    Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3218-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3584-2017·2017-10-04

    Frozen Broccoli and Cheese Soup Recalled for Plastic Pieces

    Diversified Foods and Seasonings, Inc. is recalling frozen Homestyle Broccoli and Cheese Soup because customers found pieces of plastic in the product.

    Product
    Homestyle Broccoli and Cheese Soup, 1.66 lb Plastic boil-n-bag pouches, frozen, Contains: Milk, Soy, Wheat
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1176-2017·2017-10-04

    Ketorolac Injection Recalled for Visible Crystalline Particulate

    RemedyRepack Inc. is recalling 40 vials of Ketorolac Trom 30 mg/mL Injection due to visible crystalline particulate.

    Product
    Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Ra
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3212-2017·2017-10-04

    Teleflex Recalls LMA MADgic Devices Due to Labeling Deficiencies

    Teleflex Medical is recalling LMA MADgic devices because package labels may contain missing or incomplete information.

    Product
    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3216-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3552-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling various ice cream flavors due to a process deviation where proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: , Tracker Tracks Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3496-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling specific ice cream products because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cow Dough Size: 2.5 Gal, 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1166-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Due to Expired Diluent

    PharMEDium Services is recalling 295 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3547-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling 2.5-gallon S'mores ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: S'mores Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3507-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Mint Mookie ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Mint Mookie Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3488-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Almond Delight ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Almond Delight Size: 7 oz. and Gallon
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide