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.

13451–13475 of 21617

  • ModerateFDA (Devices)·Z-0708-2017·2016-12-14

    Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates

    Navilyst Medical is recalling Xcela Power Injectable PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2017·2016-12-14

    Halyard C-Section Drapes Recalled for Manufacturing Variation

    Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

    Product
    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0716-2017·2016-12-14

    Sorin Perceval Sutureless Aortic Heart Valve Field Action

    Sorin Group USA is conducting a voluntary field action for Perceval Sutureless Aortic Heart Valves due to updated implantation procedure steps.

    Product
    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item #…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0666-2017·2016-12-14

    Saputo Recalls Whole Milk Cheese Due to Foreign Material

    Saputo Cheese USA is recalling specific lots of Vesuvio Bella Whole Milk Cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# VESUVIO BELLA; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. Distributed by US Foods UPC: #075805891658 Saputo code: #989165
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0712-2017·2016-12-14

    DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints

    DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.

    Product
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0561-2017·2016-12-14

    Coca-Cola Recalls Dr. Pepper Cherry Cans for Undeclared Corn Syrup

    The Coca-Cola Company is recalling 1,020 cases of Dr. Pepper Cherry 12oz 12-packs in California due to undeclared high-fructose corn syrup.

    Product
    Dr. Pepper Cherry, 12oz (12 pack cans), Manufactured under the authority of Doctor Pepper Company, 5301 Legacy Drive, Plano, TX.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0663-2017·2016-12-14

    Saputo Whole Milk Mozzarella Cheese Recalled for Foreign Material

    Saputo is recalling specific lots of Whole Milk Mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# MOZZERIA - Saputo; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805888948 Saputo code: #988947
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0662-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHEESECAKE FACTORY TCCFI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #075805884759 Saputo code: #988475
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0615-2017·2016-12-14

    Cre 8 It Stuffing Recalled Due to Temperature Control Issues

    Cre 8 It, Inc. is recalling stuffing mix after a complaint of sour taste indicated a storage thermometer error.

    Product
    Cre 8 It, Inc. Stuffing, 011951311916 in covered aluminum foil pans. Net Weight 2/4 lb. (3.63kg) containers per shipping case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0555-2017·2016-12-14

    Bindi Vanilla Bean Gelato Recalled for Potential Plastic Contamination

    Bindi North America is recalling 373 tubs of Vanilla Bean Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi USA Vanilla Bean Gelato 1.24 Gal Container (4.8 L) UPC 815073016557
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0705-2017·2016-12-14

    Philips IQon Spectral CT Software Defect Recall

    Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.

    Product
    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0664-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of Mozzarella Style Low Moisture Whole Milk cheese after a complaint of white plastic found in the product.

    Product
    MOZZARELLA STYLE LOW MOISTURE WHOLE MILK 8/6# HARVEST VALUE; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #758108633766 Saputo code: #988995
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0660-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ROSELI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. US Foods UPC: # #758108015111 Saputo code: #984639
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0659-2017·2016-12-14

    Saputo Mozzarella Recalled for White Plastic Contamination

    Saputo Cheese USA is recalling low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHUCK E CHEESE Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #075805845347 Saputo code: #984534
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0717-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.

    Product
    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0710-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0698-2017·2016-12-14

    Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity

    Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.

    Product
    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0558-2017·2016-12-14

    Bindi Cappucino Gelato Recalled for Plastic Strands and Cracked Lids

    Bindi North America is recalling 165 tubs of Cappucino Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi Cappucino Gelato 1.24 Gal Container (4.8L) UPC 815073016595
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0577-2017·2016-12-14

    Eola Bottling Company Recalls Oregon Rain Bottled Water Due to Mold

    Eola Bottling Company is recalling one lot of Oregon Rain bottled water due to mold. The product was distributed in Oregon and Washington.

    Product
    Label reads in part "***Oregon RAIN Natural VIRGIN WATER***" The product is packaged in a blue colored plastic bottle. 16.9 FL OZ. Case contains 12/16.9 FL OZ. or 24/16.9 FL OZ.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0656-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of Mozzarella cheese after a complaint of white plastic found in the product.

    Product
    WHOLE MILK CHEESE 8/6# LA GONDOLA; Mozzarella Cheese Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805010141 Saputo code: #1014 ;
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0658-2017·2016-12-14

    Saputo Recalls Low-Moisture Mozzarella Due to Foreign Material

    Saputo Cheese USA is recalling low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ANTONIO Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #90075805843919 Saputo code: #984391
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0557-2017·2016-12-14

    Bindi Amerana Cherry Grana Gelato Recalled for Plastic Contamination

    Bindi North America is recalling specific lots of Amerana Cherry Grana Gelato due to potential plastic contamination or cracked lids.

    Product
    Bindi Amerana Cherry Grana Gelato 1.24 Gal Container (4.8L) UPC 815073016588
    Category
    Food
    Distribution
    1 state