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.

19726–19750 of 21751

  • ModerateFDA (Food)·F-0229-2014·2013-12-04

    Florayme A Dietary Supplement Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Florayme A dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Florayme A Dietary Supplement for Complete Digestive Support, 90 count capsules Distributed by Wendy Huang, MD, MPH, DABMA 9 Professional Circle, Suite 212, Colts Neck, NJ 07722
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0402-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their 'Best When Used By' dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Basil, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and basil individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2014·2013-12-04

    Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies

    Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.

    Product
    CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0402-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2014·2013-12-04

    Synthes Material Mix Surgical Instruments Recalled Due to Material Error

    Synthes USA is recalling approximately 44 surgical instruments because a material batch was mixed with an incorrect material having lower hardness and corrosion resistance.

    Product
    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0227-2014·2013-12-04

    Nutritional Frontiers Cyb Zyme Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Nutritional Frontiers Cyb Zyme dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0382-2014·2013-12-04

    Southern Implants Recalls Tri-Nex Healing Abutments Due to Labeling Error

    Southern Implants is recalling 197 Tri-Nex healing abutments because the packages were incorrectly labeled and contained the wrong product size.

    Product
    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-002-2014·2013-11-27

    Boehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues

    Boehringer Ingelheim is recalling 10,267 bottles of Oxcarbazepine Oral Suspension because the product failed to meet resuspendability requirements.

    Product
    Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0328-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 85,646 units distributed worldwide.

    Product
    VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0356-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue

    Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.

    Product
    ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 81,382 units distributed worldwide.

    Product
    VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.

    Product
    VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0309-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides due to slide dispense issues affecting cartridge functionality.

    Product
    VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-006-2014·2013-11-27

    L. Perrigo Recalls Infants' Acetaminophen Due to Unmarked Dosing Syringes

    L. Perrigo is recalling 108,828 bottles of infants' acetaminophen because some cartons may contain dosing syringes without dose markings.

    Product
    EQUATE PAIN AND FEVER — EQUATE PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS BUN/UREA Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS BUN/UREA Slides because of slide dispense issues. The recall affects units distributed worldwide.

    Product
    VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0339-2014·2013-11-27

    Synovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors

    Synovis is recalling Dura-Guard and Vascu-Guard patches because specific units were shipped in divided cell configurations with a specific revision of the Instructions for Use.

    Product
    Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-014-2014·2013-11-27

    Pfizer Recalls Aldactone Tablets Due to Unapproved Manufacturing Site

    Pfizer is recalling Aldactone (spironolactone) 100 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    ALDACTONE — ALDACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0332-2014·2013-11-27

    ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Particulate Matter

    ConMed is recalling 147 Altrus Thermal Tissue Fusion handpieces because they were exposed to higher-than-acceptable particulate matter during manufacture.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0368-2014·2013-11-27

    Philips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors

    Philips is recalling EPIQ 7 Ultrasound Systems because using the International System Date Format may cause calculation errors in Gestational Age and Established Due Date.

    Product
    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide