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.

13476–13500 of 21617

  • ModerateFDA (Devices)·Z-0704-2017·2016-12-14

    Ultradent Recalls UltraSeal XT Plus Clear Refill Due to Labeling Error

    Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Lot BD79T, because the package was mislabeled with an incorrect part number.

    Product
    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2017·2016-12-14

    Siemens Recalls SOMATOM Force CT Systems for Software Bugs

    Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

    Product
    SOMATOM Force, System x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2017·2016-12-14

    Merge PACS software recall for horizontal image cut lines

    Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0655-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

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

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ARREZZIO IMPERIAL; UPC: 0 74865 30185 5 Saputo code: #101379 ;
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0667-2017·2016-12-14

    Saputo Mozzarella Supreme Recalled for Foreign Material Contamination

    Saputo Cheese USA is recalling Mozzarella Supreme due to a report of white plastic found in the product.

    Product
    MOZZARELLA SUPREME 8/6# CONTADINO ; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805888825 Saputo code: #988882
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0718-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2017·2016-12-14

    Randox Magnesium IVD Reagent Recalled for Carryover Interference

    Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.

    Product
    Magnesium on RX Imola analyser IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0661-2017·2016-12-14

    Saputo Recalls Arrezzo Classic Whole Milk Cheese Due to Foreign Material

    Saputo Cheese USA is recalling Arrezzo Classic whole milk cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# ARREZZIO CLASSIC; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #074865692694 Saputo code: #987371
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0675-2017·2016-12-14

    A&W Cream Soda Recalled for Caffeine Presence Despite Labeling

    Chesterman Co is recalling A&W Cream Soda, 20 FL OZ, Caffeine Free, because testing revealed the presence of caffeine despite the product being labeled as caffeine-free.

    Product
    A&W Cream Soda, 20 FL OZ, Caffeine Free
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0700-2017·2016-12-14

    Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation

    Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.

    Product
    Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2017·2016-12-14

    DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints

    DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.

    Product
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0719-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Test Pack dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2017·2016-12-14

    Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants

    Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.

    Product
    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0665-2017·2016-12-14

    Saputo Recalls Whole Milk Cheese Due to Foreign Material

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

    Product
    WHOLE MILK CHEESE 8/6# MAGIC MOZZI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805890378 Saputo code: #989037
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0695-2017·2016-12-14

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient…
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Food)·F-0556-2017·2016-12-14

    Bindi USA Chocolate Gelato Recalled for Potential Plastic Contamination

    Bindi North America is recalling 177 tubs of Bindi USA Chocolate Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi USA Chocolate Gelato 1.24 Gal Container (4.8 L) UPC 815073016564
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0694-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.

    Product
    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and…
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Food)·F-0547-2017·2016-12-07

    Mel-O Cream Donuts Recalls Hy Vee Long Shells Due to Fingertip Contamination

    Mel-O Cream Donuts International is recalling Hy Vee Long Shells because a human fingertip was found in the product filling line.

    Product
    Hy Vee Long Shells (Red Raspberry Filled); Best If Used By 02/26/2017; Batch 162734720; NET WT 26.48 Pounds; Approximate Unit Count: 84 units
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0681-2017·2016-12-07

    Synthes 0.76 mm Drill Bit Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 84 units of 0.76 mm Drill Bits that may be incorrectly labeled and actually contain 1.1 mm drill bits.

    Product
    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2017·2016-12-07

    MicroPort Orthopedics Recalls Lineage Liners Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling 5,009 Lineage Liners used with Conserve metal heads due to a suspected tissue reaction to metal debris.

    Product
    Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2017·2016-12-07

    Spectranetics Recalls Turbo Elite Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling Turbo Elite Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2017·2016-12-07

    Spectranetics Recalls ELCA Coronary Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling ELCA Coronary Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2017·2016-12-07

    Burel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling UROLET MB Urinary Antiseptic tablets because manufacturing deficiencies may cause the product to fail potency or uniformity tests.

    Product
    UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0540-2017·2016-12-07

    Mel-O-Cream and Hy-Vee Jumbo Pershing Cinnamon Rolls Recalled for Foreign Object

    Mel-O Cream Donuts International is recalling Jumbo Pershing Cinnamon Rolls because a human fingertip was found in the product filling line.

    Product
    Jumbo Pershing (Cinnamon) Rolls; NET WT 11.25 and 16.1 Pounds; Approximate Unit Count [Per Case]: 6-8 Dozen; Brands: Mel-O-Cream and Hy-Vee
    Category
    Food
    Distribution
    3 states