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.

15426–15450 of 21645

  • ModerateFDA (Drugs)·D-0560-2016·2016-01-13

    PD-Rx Recalls Azithromycin Tablets Due to Inadequate Complaint Investigation

    PD-Rx Pharmaceuticals is recalling 45,022 bottles of Azithromycin Tablets, USP, 250 mg, because the manufacturer did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2016·2016-01-13

    Siemens Acute Care CTNI TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2016·2016-01-13

    Baxter CLEARLINK Blood Bag Spike Adapter Recalled for Particulate Matter

    Baxter Healthcare is recalling CLEARLINK Blood Bag Spike Adapters due to potential dark loose particulate matter on the spike.

    Product
    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2016·2016-01-13

    Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing

    Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.

    Product
    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0618-2016·2016-01-13

    Siemens Acute Care MYO DilPak Recall Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0467-2016·2016-01-13

    Nicomex Velitas Candies Candles Recalled for Undeclared Food Dyes

    Nicomex Inc. is recalling Velitas Candies Candles because laboratory analysis found undeclared FD&C Red #3 and Yellow #5 dyes.

    Product
    Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0581-2016·2016-01-13

    Natus Quantum System Recalled for Reversed Signal Polarity Display

    Natus Medical is recalling 56 Quantum Systems with NeuroWorks 8.1 software because incoming signals display with reversed polarity.

    Product
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0582-2016·2016-01-13

    Vidco MDP 2000 Remote Patient Monitoring Systems Recalled for Freezing

    Vidco, Inc. is recalling 59 MDP 2000 Series Remote Patient Monitoring Systems because they may freeze and fail to reset without a power cycle.

    Product
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0585-2016·2016-01-13

    Synthes 13.5mm Medullary Reamer Head Recalled for Dimensional Mismatch

    Synthes (USA) Products LLC is recalling 65 units of 13.5mm Medullary Reamer Heads that are actually 14mm. The devices are distributed nationwide.

    Product
    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0584-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled Birmingham Hip Resurfacing Modular Heads

    Smith & Nephew is recalling 16 Birmingham Hip Resurfacing Modular Heads in the US because they were incorrectly labeled as a different device type not cleared for US marketing.

    Product
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2016·2016-01-13

    Siemens Acute Care pBNP TestPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0600-2016·2016-01-13

    KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks

    KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.

    Product
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2016·2016-01-06

    Walgreens Recalls Folic Acid Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 23 folic acid syringes compounded in Texas due to a lack of assurance of sterility.

    Product
    Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0457-2016·2016-01-06

    The Dough Shop Recalls Pizza Dough Balls Due to Vinyl Glove Contamination

    The Dough Shop is recalling one lot of 5-ounce pizza dough balls because a piece of vinyl glove was found in the product.

    Product
    CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4..
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0456-2016·2016-01-06

    Baker's Best Vitamin B6 Supplement Recalled for Low Nutrient Levels

    Pure Source, Inc. is recalling Baker's Best Maximum Mind & Memory Formula because the Vitamin B6 level is below the amount declared on the label.

    Product
    Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg. Distributed by Baker's Best Health Products, Inc. Wixom, MI
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0437-2016·2016-01-06

    Amcane Sugar Recalls Bulk Refined Sugar Due to Foreign Material

    Amcane Sugar LLC is recalling 526,000 lbs of bulk refined sugar because it contains small pieces of brass.

    Product
    Bulk refined sugar. CON AA in 50lb paper bags, 2000 and 2200 poly super totes
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0559-2016·2016-01-06

    PD-Rx Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    PD-Rx Pharmaceuticals is recalling 9 bottles of Clonidine Hydrochloride Tablets, 0.1 mg, distributed in Alabama due to cGMP deviations.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0562-2016·2016-01-06

    Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2016·2016-01-06

    Biomerieux Recalls Granada Biphasic Broth Due to Missing FDA Clearance

    Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth because the product lacks required FDA 510(k) clearance for marketing in the United States.

    Product
    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0564-2016·2016-01-06

    Biomet 3i Recalls Radiographic Transparencies Due to Undersized Images

    Biomet 3i is recalling 686 radiographic transparencies because the images are undersized, which may affect dental implant measurements.

    Product
    Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0336-2016·2016-01-06

    Friendly Farms Greek Peach Parfait Recalled for Gluten Mislabeling

    Ehrmann Arizona Dairy is recalling Friendly Farms Greek Peach Parfait because the packaging displays a gluten-free logo despite containing wheat flakes.

    Product
    Friendly Farms Greek Peach Parfait Nonfat Yogurt net wt. 5.3 oz (150g) Distributed by ALDI Inc., Batavia, IL 60510
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0555-2016·2016-01-06

    Merge Healthcare Recalls Unvalidated Cardio and HEMO Software Versions

    Merge Healthcare is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software distributed to three customers before complete in-house validation.

    Product
    Merge Cardio with software version 10.1 LA.
    Category
    Medical Device
    Distribution
    3 states