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.

11401–11425 of 21617

  • ModerateFDA (Devices)·Z-0547-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification

    Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guidin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0525-2018·2018-02-14

    ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products

    ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.

    Product
    SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2018·2018-02-14

    Siemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias

    Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.

    Product
    ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0719-2018·2018-02-14

    Wienke's Market Cherry Rhubarb Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Cherry Rhubarb Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Cherry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00216. Refrigerate after opening. Ingredients: cherries, rhubarb, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0594-2018·2018-02-14

    Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations

    Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active ingredient did not meet all intended specifications.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0524-2018·2018-02-14

    Siemens Syngo.plaza PACS Software Recall for Workflow Display Error

    Siemens is recalling 76 Syngo.plaza systems with SW VB20A because prior studies may not replace correctly in all workflow steps, potentially showing outdated images.

    Product
    Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0793-2018·2018-02-14

    Rico Tofu Breakfast Burrito Recalled for Undeclared Soy

    Rico Brand is recalling 164 frozen Tofu Breakfast Burritos because they contain undeclared soy. The product was distributed to 20 retail stores in Utah.

    Product
    Rico Tofu Breakfast Burrito, 12 oz, wrapped in white paper. Frozen.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0533-2018·2018-02-14

    MedComp Recalls CT Port Kits Packaged With Incorrect Needle Size

    Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.

    Product
    6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0338-2018·2018-02-14

    McKesson Recalls Subpotent Megestrol Acetate Oral Suspension

    McKesson Packaging Services is recalling Megestrol Acetate Oral Suspension because stability testing found the drug was subpotent.

    Product
    Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2018·2018-02-14

    3M Recalls ACE Ultra Lite Ankle Braces Due to Mold Contamination

    3M is recalling specific sizes of ACE Ultra Lite Ankle Braces because mold was found on non-patient contact surfaces. The mold was identified as Aspergillus candidus.

    Product
    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-0506-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0542-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Levels

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because they contain a degradant called Fentanyl-n-Oxide that exceeds safety limits.

    Product
    Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2018·2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0425-2018·2018-02-14

    Millennium Pharmaceuticals Recalls VELCADE Injection Vials Due to Defective Crimps

    Millennium Pharmaceuticals is recalling 154,372 vials of VELCADE (bortezomib) for injection due to confirmed reports of loose vial crimps.

    Product
    VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distribu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0724-2018·2018-02-14

    Wienke's Market Hot Pepper Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Hot Pepper Jam because it contains butter, an ingredient not declared on the label.

    Product
    Wienke's Market Hot Pepper Jam, Net Wt. 8 oz (226g), UPC 14106-00221. Refrigerate after opening. Ingredients: sweet red peppers, onion, hot peppers, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0773-2018·2018-02-14

    Titan Potato Puffs Recalled for Undeclared Sodium Bisulfite Ingredient

    Empresas Barsan, Inc. is recalling Titan potato puffs in Puerto Rico because the label fails to declare sodium bisulfite as an ingredient.

    Product
    TITAN, 24 rellenos de papas, (potato puffs), Net WT 6.75 LB (pounds)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0809-2018·2018-02-14

    Bobo's Coconut Oat Bars Recalled Due to Mold Contamination

    Simply Delicious, Inc. is recalling Bobo's Coconut Oat Bars because they may contain mold. The recall covers 588 master cases distributed nationwide.

    Product
    Bobo's Coconut Oat Bar 3oz. Packaged in overwrap film per single bar
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2018·2018-02-14

    Flawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.

    Product
    Relumins Vitamin C Solvent ampules
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0518-2018·2018-02-14

    Philips Brilliance 64 CT System Recalled for Software Issues

    Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.

    Product
    Philips Brilliance 64 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0540-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.

    Product
    Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2018·2018-02-14

    Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety Deluxe Bone Marrow Biopsy/Aspiration Trays because they may contain loose polypropylene foreign matter.

    Product
    Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0739-2018·2018-02-14

    Wienke's Apple Butter Recalled for Undeclared Butter Ingredient

    Wienke LLC is recalling No Sugar Added Apple Butter because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market No Sugar Added Apple Butter, Net Wt. 8 oz (226g), UPC 14106-00300. Refrigerate after opening. Ingredients: apples, cinnamon, cloves, allspice.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0542-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety-Deluxe Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0543-2018·2018-02-14

    Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter

    Robert Busse & Co. is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays due to the presence of loose polypropylene foreign matter.

    Product
    Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide