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.

14501–14525 of 21645

  • ModerateFDA (Food)·F-1495-2016·2016-06-22

    Oasis Foods Soybean Oil Recalled for Foreign Object Contamination

    Oasis Foods is recalling 35 lb bottles of soybean oil because they may contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Soybean Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 11099 1
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1984-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1505-2016·2016-06-22

    Silver Source Clear Fry Oil Recalled for Foreign Object Contamination

    Oasis Trading Co. is recalling 13,740 containers of Silver Source Clear Fry Oil because the bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Silver Source Clear Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food group, Richmond, VA 23238, UPC 00806795022353
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1994-2016·2016-06-22

    Anspach Universal Battery Charger II Recalled for Failure to Charge

    The Anspach Effort, Inc. is recalling 1,992 Universal Battery Charger II units because they enter safe mode and fail to charge batteries.

    Product
    Universal Battery Charger II (UBC II)
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Food)·F-1488-2016·2016-06-22

    Oasis Foods Canola Fry Shortening Recalled for Foreign Material

    Oasis Foods is recalling Canola Fry Shortening because 35 lb bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1956-2016·2016-06-22

    Beckman Coulter Access 2 Immunoassay System Recall for Thermal Component Defects

    Beckman Coulter is recalling four Access 2 Immunoassay Systems because missing thermal components may cause internal temperature excursions, delaying patient result reporting.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1035-2016·2016-06-22

    Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities

    Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.

    Product
    Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2016·2016-06-22

    Miami Fat Supply Recalls Red Head 2 Fat Harvesting Canisters

    Miami Fat Supply is recalling 443 Red Head 2 Reusable Fat Harvesting Canisters because they were marketed without FDA clearance and are not approved for multiple use.

    Product
    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1980-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1981-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters

    Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2016·2016-06-22

    Integra Recalls TS Series Depth Gauges for Incorrect Markings

    Integra LifeSciences is recalling 71 TS Series Depth Gauges because some units exceed length specifications or have incorrect millimeter markings.

    Product
    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2001-2016·2016-06-22

    Natus neoBLUE Phototherapy System Recall for Warning Label Update

    Natus Medical is recalling 13,541 neoBLUE Phototherapy systems to add a warning statement to the instructions and provide a laminated Quick Guide for each device.

    Product
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1499-2016·2016-06-22

    Chef's Quality Clear Liquid Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Clear Liquid Shortening because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Clear Liquid Shortening, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00481 2
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1508-2016·2016-06-22

    Silver Source Soy Salad Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling 1,200 containers of Silver Source Soy Salad Oil due to reports of high density polyethylene resin trim rings in the bottles.

    Product
    Silver Source Soy Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022346
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1939-2016·2016-06-15

    Stryker Recalls Maestro Air Motor Pneumatic Cranial Drill Units

    Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.

    Product
    Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1717-2016·2016-06-15

    Philips Ingenuity CT System Recalled for Software Defects

    Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1943-2016·2016-06-15

    DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error

    DePuy Synthes is voluntarily recalling Norian Drillable Inject 5 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.

    Product
    Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2016·2016-06-15

    Ellipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions

    Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.

    Product
    Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1938-2016·2016-06-15

    Teleflex Recalls Sterile Tracheal Tubes Due to Size Labeling Error

    Teleflex Medical is recalling 6,390 sterile tracheal tubes because some units labeled as 7mm may actually be 7.5mm.

    Product
    Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0975-2016·2016-06-15

    Aidarex Recalls Chlorhexidine Gluconate Oral Rinse Due to Impurity

    Aidarex Pharmaceuticals is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse because the product failed impurity specifications.

    Product
    CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1932-2016·2016-06-15

    Beckman Coulter Uric Acid Reagent Recalled for False Low Results

    Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.

    Product
    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2016·2016-06-15

    Beckman Coulter Recalls Triglyceride Assay Due to Dipyrone Interference

    Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.

    Product
    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2016·2016-06-15

    Integrated Science Systems Recalls Sure Vue Staph Identification Kits

    Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.

    Product
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2016·2016-06-15

    Remel Recalls Oxoid Nitrocefin In Vitro Diagnostic Reagents

    Remel Inc is recalling Oxoid Nitrocefin reagents because individual bottles may produce weak reactions, leading to delayed or false negative beta-lactamase test results.

    Product
    Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1935-2016·2016-06-15

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Incorrect Instruction Manual

    Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.

    Product
    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic…
    Category
    Medical Device
    Distribution
    0 states