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.

14476–14500 of 21645

  • ModerateFDA (Devices)·Z-2007-2016·2016-06-29

    Siemens Biograph 40 PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling five Biograph 40 PET/CT scanners due to a potential for unexpected Standardized Uptake Value (SUV) readings when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1039-2016·2016-06-29

    Profarma Recalls tabcin ACTIVE M.R. Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is voluntarily recalling 42 boxes of tabcin ACTIVE M.R. Capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1043-2016·2016-06-29

    Profarma Recalls 1% Clotrimazole Cream Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 79 tubes of 1% Clotrimazole cream due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    1% Clotrimazol cream, 30 mg tube, UPC 501318644335
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2016·2016-06-29

    Medtronic Recalls Two EverFiex Stents Due to Outer Box Mislabeling

    Medtronic is recalling two Protege EverFiex Self-expanding Peripheral Stent Systems from lot A164580 because the outer box size label may not match the device inside.

    Product
    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2025-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 25 Biograph mCT Flow 64-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling three Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2014-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 16 Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 13 Biograph mCT Flow Edge-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2016·2016-06-22

    Ethicon Recalls EVARREST Fibrin Sealant Patch Due to Labeling Error

    Ethicon is recalling 228 units of EVARREST Fibrin Sealant Patch because the expiration date field on the foil pouch labels contains the text '0-bad' instead of the valid date.

    Product
    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1983-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

    Navilyst Medical is recalling 376 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1989-2016·2016-06-22

    Excelsior Heparin Lock Flush Syringes Recalled for Potency Failure

    Excelsior Medical Corp is recalling specific lots of Heparin Lock Flush syringes because they failed potency testing.

    Product
    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1502-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Corn Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling Chef's Quality Corn Oil because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Corn Oil, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00934 3
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1986-2016·2016-06-22

    Navilyst Medical Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 10 BioFlo Hybrid PICC catheter kits manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, 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-1993-2016·2016-06-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Display Obstruction

    Physio-Control is recalling LIFEPAK 15 monitor/defibrillators with the EtCO2 feature because the respiratory rate display may obscure the leading digit of the EtCO2 value.

    Product
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1486-2016·2016-06-22

    Brookshire Brothers Recalls Fresh Harvest Ice Due to Foreign Object

    Brookshire Brothers is recalling Fresh Harvest Ice in 8 and 16-pound bags because a foreign object was found in the product.

    Product
    Fresh Harvest Ice NET WT 8 LB and Fresh Harvest Ice NET WT 16 LB packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1032-2016·2016-06-22

    Valeant Recalls Mislabelled Lodrane D Capsules Due to Incorrect Ingredient Labeling

    Valeant Pharmaceuticals is recalling 3,827 bottles of Lodrane D capsules because the outer cartons were mislabeled with the wrong active ingredient.

    Product
    Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2016·2016-06-22

    FSC Laboratories Recalls Flexichamber Holding Chambers Due to Seal Defects

    FSC Laboratories is recalling 1,435 Flexichamber Anti-Static Valved Collapsible Holding Chambers because the seal around the mouthpiece was torn or loose.

    Product
    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1509-2016·2016-06-22

    Silver Source Canola Fry Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Silver Source Clear Canola Fry Oil because 35 lb bottles were reported to contain a high density polyethylene resin trim ring.

    Product
    Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 7
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1498-2016·2016-06-22

    Oasis Foods Soybean Oil Recalled for Foreign Material Contamination

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

    Product
    Oasis Foods Soybean Cooking & Frying Oil, Net Wt. 35 LB (15.88), Manufactured d by Oasis Foods Company. Hillside, NJ 07205, UPC 7 32146 11212 4
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1504-2016·2016-06-22

    Chef's Quality Canola Oil Recalled for Foreign Object Contamination

    Oasis Trading Co. is recalling Chef's Quality 100% Canola Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality 100% Canola Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00935 0
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1497-2016·2016-06-22

    Oasis Foods Liquid Shortening Recalled for Foreign Material Contamination

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

    Product
    Oasis Foods Golden Fry Clear Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10458 7
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1489-2016·2016-06-22

    Town & Country Pan & Grill Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Town & Country Pan & Grill Oil because 35 lb bottles were found to contain high density polyethylene resin trim rings.

    Product
    Town & Country Pan & Grill Oil Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 24948 4
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1030-2016·2016-06-22

    Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

    Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

    Product
    Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1038-2016·2016-06-22

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because they contain a known impurity above approved specification levels.

    Product
    Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
    Category
    Drug
    Distribution
    Distributed nationwide