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.

15401–15425 of 21645

  • ModerateFDA (Devices)·Z-0647-2016·2016-01-20

    Brainlab Brain Metastases Software Recall for Image Display Errors

    Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0476-2016·2016-01-20

    Garden Harvest Recalls Bino's Italian Hot Peppers for Unlicensed Manufacturing

    Garden Harvest is recalling Bino's Italian Hot Peppers because the firm was manufacturing acidified foods without a license.

    Product
    BINO'S ITALIAN HOT PEPPERS Ingredients: Hungarian hot peppers w/seeds, onions, vinegar, garlic, sugar, Bell peppers, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00013 5 NET WT 32 oz UPC 8 67752 00011 1
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0566-2016·2016-01-20

    Teva Recalls Amphetamine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,717 bottles of mixed amphetamine salts tablets because stability testing revealed high impurity levels.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0499-2016·2016-01-20

    Garden Harvest Recalls Roasted Mediterranean Spicy Pepper Relish for Unlicensed Production

    Garden Harvest is recalling 143 cases of Roasted Mediterranean Spicy Pepper Relish because the firm was manufacturing acidified foods without a license.

    Product
    ROASTED MEDITERRANEAN SPICY PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***Habanero Pepper. UPC 8 63131 00011 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0495-2016·2016-01-20

    Garden Harvest Recalls Patty's Peppers for Unlicensed Acidified Food Manufacturing

    Garden Harvest is recalling Patty's Peppers Hungarian Hot & Sweet Peppers because the firm was manufacturing acidified foods without a license.

    Product
    PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Uncle Joe's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot Wax Peppers, Garlic, Vinegar, All Natural Ketchup, Sugar, Canola Oil, pattyspeppers.com UPC 7 48252 07486 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0493-2016·2016-01-20

    Garden Harvest Citrus Salsa Recalled for Unlicensed Acidified Food Production

    Garden Harvest is recalling 80 cases of sweet & tangy citrus salsa because the firm was manufacturing acidified foods without a license.

    Product
    Kiem's Garden Harvest sweet & tangy citrus salsa 1 PT (14 oz 397g) Ingredients:tomatoes, onions***lemon juice concentrate, lime juice concentrate***Manufactured by: Keim's Garden Harvest (937) 515-4518 2232 Honeysuckle Lane Wellston, OH 45692 UPC 6 09722 32346 8
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0654-2016·2016-01-20

    Zimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch

    Zimmer Biomet is recalling 52 orthopedic plates because the package labels did not match the products inside.

    Product
    Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-0494-2016·2016-01-20

    Garden Harvest Recalls Patty's Peppers for Unlicensed Acidified Food Production

    Garden Harvest is recalling Patty's Peppers Hungarian Hot & Sweet Peppers because the firm was manufacturing acidified foods without a license.

    Product
    PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Mom's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot and Sweet Peppers, Garlic, Canola Oil, Vinegar, Salt, Oregano. pattspeppers.com UPC 7 48252 07478 2
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0473-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Acidified Salsa Products

    Garden Harvest is recalling 52 cases of A Bit of a Bite Salsa Three Sisters because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA THREE SISTERS NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, ORGANIC BLACK BEANS, FRESH CORN***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95418 1
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0638-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 188 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0475-2016·2016-01-20

    Garden Harvest Recalls Barney's Hot Peppers Due to Unlicensed Manufacturing

    Garden Harvest is recalling 106 cases of Barney's Hot Peppers because the firm was manufacturing acidified foods without a license.

    Product
    Barney's Hot Peppers 16 oz (443 ml) Ingredients: Hot Peppers, Canola Oil, Garlic, Oregano, Salt, Acidic Calcium Sulfate Distributed by: Barney's Hot Peppers 2061 Elm Road Warren, Ohio 44483 330-964-2922 UPC # 7 01807 99994 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0471-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Acidified Salsa Products

    Garden Harvest is recalling 45 cases of A Bit of a Bite Salsa Melissa Medium because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA MELISSA MEDIUM NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS, FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95416 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0597-2016·2016-01-13

    Siemens Syngo X-Workplace Software Recall for Incorrect Measurement Display

    Siemens is recalling Syngo X-Workplace software version VD10E because it may display incorrect length measurements, potentially leading to the selection of medical devices of the wrong size.

    Product
    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2016·2016-01-13

    Steris Amsco Warming Cabinet Recalled for Incorrect Temperature Labeling

    Steris Corporation is recalling Amsco Warming Cabinets because the quick reference magnet displays incorrect Fahrenheit to Celsius conversions and default temperatures.

    Product
    AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2016·2016-01-13

    Ethicon Recalls Gynecare Thermachoice III Uterine Balloon Therapy System

    Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System because stability data does not support the labeled two-year shelf life.

    Product
    Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2016·2016-01-13

    Siemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2016·2016-01-13

    Siemens Acute Care MYO TestPak Barcode Labels May Not Scan

    Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0561-2016·2016-01-13

    PD-Rx Pharmaceuticals Recalls Azithromycin 500 mg Tablets for cGMP Deviations

    PD-Rx Pharmaceuticals is recalling Azithromycin 500 mg tablets because the original manufacturer did not adequately investigate customer complaints, resulting in cGMP deviations.

    Product
    Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0590-2016·2016-01-13

    Zimmer NexGEN Tibial Components Recalled Due to Labeling Error

    Zimmer Manufacturing B.V. is recalling specific NexGEN System tibial components because a carton was mislabeled, containing a different component than indicated.

    Product
    NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0611-2016·2016-01-13

    Siemens Acute Care DDMR TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0608-2016·2016-01-13

    Otto Bock Recalls Modular Polycentric EBS Knee Joints Due to Service Error

    Otto Bock is recalling 40 Modular Polycentric EBS Knee Joints serviced between April 2015 and November 2015 because the wrong Loctite was used during repair.

    Product
    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2016·2016-01-13

    Baxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter

    Baxter Healthcare is recalling INTERLINK Y-Type Solution Sets due to potential dark particulate matter on the spike adapter.

    Product
    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide