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.

16901–16925 of 21645

  • ModerateFDA (Devices)·Z-0946-2015·2015-01-14

    Siemens Recalls Dimension Vista Myoglobin Calibrator Due to Positive Result Shift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Myoglobin Calibrators because they may cause test results to shift up to 12% higher than expected.

    Product
    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0938-2015·2015-01-14

    Stryker Orthobiologics Recalls Imbibe Bone Marrow Aspiration Needles

    Stryker Orthobiologics is recalling Imbibe Bone Marrow Aspiration Needles due to a potential breach in the inner or outer packaging pouches.

    Product
    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0765-2015·2015-01-14

    Vintage Pure Bee Flower Honey Recalled for Sulfamethazine Levels

    Vintage Food Corp. is recalling 233 cases of Vintage Pure Bee Flower Honey because the product contains higher than recommended levels of sulfamethazine.

    Product
    Vintage Pure Bee Flower Honey, Net Weight 16.4 oz (465g), Packaged in a Glass Jar, Product of Turkey, Imported by: Vintage Food Corp., 849 Newark Tpke, Kearny, NJ 07032, USA, UPC 603608629903
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0332-2015·2015-01-14

    Par Pharmaceutical Recalls HydrALAZINE Tablets Due to Aluminum Particles

    Par Pharmaceutical is recalling one lot of HydrALAZINE Hydrochloride tablets because small aluminum particles were found in the product.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0937-2015·2015-01-14

    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Recall

    Stryker Orthobiologics is recalling Imbibe Aliquot Needle Bone Cement Needles due to potential breaches in the inner or outer packaging pouches.

    Product
    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2015·2015-01-14

    Alere INRatio Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.

    Product
    INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2015·2015-01-14

    Spinal Elements Recalls Ti-Bond Marketing Literature Due to Misleading Claims

    Spinal Elements is recalling Ti-Bond marketing literature because the content regarding the Ti-Bond coating is unsubstantiated and misleading for spine applications.

    Product
    Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2015·2015-01-14

    Right Value Recalls Glutathione Injectable Due to Incorrect Gas Formulation

    Right Value Drug Stores is recalling specific lots of Glutathione 200 mg/mL Injectable because an incorrect gas was used to remove oxygen from the vials.

    Product
    Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0338-2015·2015-01-14

    Actavis Recalls Gabapentin Capsules Due to Physical Defects

    Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0932-2015·2015-01-14

    Baxter Amia Automated PD Systems Recalled for Battery Charging Error

    Baxter Healthcare is recalling 55 Amia Automated PD systems due to a battery charging error that prevents the device from functioning.

    Product
    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2015·2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected units were distributed internationally.

    Product
    ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0900-2015·2015-01-07

    Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect

    Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.

    Product
    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0327-2015·2015-01-07

    Jaymac Pharmaceuticals Recalls J-TAN D PD Drops Due to Dye Labeling Error

    Jaymac Pharmaceuticals is recalling J-TAN D PD Drops because the product is labeled 'Dye Free' but contains Red Dye 40.

    Product
    J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0877-2015·2015-01-07

    Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations

    Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.

    Product
    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2015·2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.

    Product
    ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0319-2015·2014-12-31

    Walgreens Aspirin Free Tension Headache Caplets Recalled for Undeclared Sucralose

    LNK International recalled specific lots of Walgreens Aspirin Free Tension Headache Caplets because they contain sucralose, an ingredient not listed on the label.

    Product
    Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2015·2014-12-31

    Unapproved Dental Implants Recalled by Instradent USA

    Instradent USA is recalling 13 units of Neodent Titamax WS Cortical Implants because the product is not approved for use in the US.

    Product
    Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0861-2015·2014-12-31

    US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues

    US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.

    Product
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0849-2015·2014-12-31

    Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation

    Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.

    Product
    Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0870-2015·2014-12-31

    Maquet Pediatric Oxygenator Recalled for Incorrect Coating Labels on Packaging

    Maquet is recalling 28 units of Quadrox-ID Pediatric Diffusion Membrane Oxygenators because the cartons and shipping containers incorrectly display Softline coating labels instead of Bioline.

    Product
    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0847-2015·2014-12-31

    Natus neoBLUE 2 Phototherapy LED Kit Recalled for Higher Light Intensity

    Natus Medical is recalling replacement LED PCB kits for neoBLUE 2 phototherapy systems because they produce higher light intensity than the original device.

    Product
    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0325-2015·2014-12-31

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Defects

    Zydus Pharmaceuticals USA is recalling 19,536 units of Benzonatate capsules because some are wet or leaking. The recall is nationwide.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0309-2015·2014-12-31

    Vann Healthcare Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

    Vann Healthcare Services is recalling Hydroxyprogesterone Caproate vials because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility.

    Product
    Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0851-2015·2014-12-31

    Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues

    Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.

    Product
    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
    Category
    Medical Device
    Distribution
    0 states