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.

15351–15375 of 21645

  • ModerateFDA (Devices)·Z-0656-2016·2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Cutter Shaver Blades Due to Labeling Error

    DePuy Mitek is recalling FMS neXtra 3.5mm Full Radius Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0658-2016·2016-01-27

    DePuy Mitek Recalls FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 115 units of FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0572-2016·2016-01-27

    Mutual Pharmaceutical Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Substance

    Mutual Pharmaceutical Company is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets due to the presence of a polyethylene piece.

    Product
    Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0576-2016·2016-01-27

    Energique Homeopathic Spray Recalled for Microbial Contamination

    Grato Holdings is recalling Energique homeopathic topical spray due to out-of-specification microbial counts. The product was distributed nationwide and to Canada and Guatemala.

    Product
    Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0579-2016·2016-01-27

    Energique Headache Spray Recalled for Microbial Contamination

    Grato Holdings is recalling Energique Headache Pain & Sinus Pressure Relief Topical Spray due to microbial contamination.

    Product
    Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2016·2016-01-27

    Fukuda Denshi Patient Monitors Recalled for Battery Malfunction

    Fukuda Denshi is recalling 95 DynaScope patient monitors in the US due to a potential short-term battery error caused by a damaged Lithium-Ion capacitor.

    Product
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0662-2016·2016-01-27

    Innovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error

    Innovasis is recalling two lots of Excella II titanium spine rods because they were packaged with each other's labels.

    Product
    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateUSDA FSIS·010-2016·2016-01-25

    Whole Foods Recalls Frozen Pepperoni Pizza Due to Undeclared Pork

    Whole Foods is recalling frozen pepperoni pizzas because they contain undeclared pork pepperoni. No adverse reactions have been reported.

    Product
    Whole Foods Recalls Frozen Pizza Products Due to Misbranding
    Category
    Food
    Distribution
    7 states
  • ModerateUSDA FSIS·008-2016·2016-01-22

    Pinnacle Foods Recalls Chili Products Due To Undeclared MSG

    Pinnacle Foods is recalling approximately 549,539 pounds of Armour Chili No Beans because the products contain Monosodium Glutamate (MSG), which is not declared on the label.

    Product
    Pinnacle Foods, Inc. Recalls Chili Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0481-2016·2016-01-20

    Garden Harvest Recalls Pickled Beets Manufactured Without License

    Garden Harvest is recalling Dutch Country Kettles Homemade Pickled Beets because the firm was manufacturing acidified foods without a license.

    Product
    DUTCH COUNTRY KETTLES HOMEMADE Pickled Beets Ingredients: Beets, Water, Vinegar, Sugar, Salt. Dutch Country Kettles 6732 Pavey Road. Leesburg, OH 45135 1-937-780-6718 1 Pint (1 lb. 3oz) 538g UPC 6 98241 12224 9 & 1 Quart (32 oz) 907g UPC 6 98241 14444 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0487-2016·2016-01-20

    Keim's Garden Harvest Pickled Beets Recalled for Unlicensed Manufacturing

    Keim's Garden Harvest pickled beets are being recalled because the manufacturer was producing acidified foods without a required license.

    Product
    Keim's Garden Harvest pickled beets Ingredients: red beets, water, sugar, vinegar, spices, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 14 oz UPC 6 09722 32336 9, 32 oz UPC 6 09722 32339 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0479-2016·2016-01-20

    Garden Harvest Recalls Cleveland Pickle Garlic Dill for Unlicensed Manufacturing

    Garden Harvest is recalling 146 cases of Cleveland Pickle Original Garlic Dill because the firm was manufacturing acidified foods without a license.

    Product
    Cleveland Pickle Original Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0636-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label

    Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 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-0509-2016·2016-01-20

    Snack Depot Recalls Mislabeled Roasted Seasoned Himego Fish

    Snack Depot is recalling Roasted Seasoned Himego Fish (spicy) because the product was mislabeled and misidentified. The recall covers 30 cases distributed in California.

    Product
    Roasted Seasoned Himego Fish (spicy) Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0500-2016·2016-01-20

    Garden Harvest Recalls Sugar & Spice Gourmet Beets for Unlicensed Manufacturing

    Garden Harvest is recalling 50 cases of Sugar & Spice Gourmet Beets because the firm was manufacturing acidified foods without a license.

    Product
    SEASONAL SELECTIONS SUGAR & SPICE GOURMET BEETS NET WT 16 OZ (1 lb) 453g INGREDIENTS: Beets, Vinegar, Sugar, Whole Allspice, Salt, Cinnamon Sticks SEASONAL SELECTIONS P.O. BOX 251 Waynesville, OH 45060 UPC 8 57596 00308 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0483-2016·2016-01-20

    Garden Harvest Recalls Herbert's Chow-Chow Due to Unlicensed Manufacturing

    Garden Harvest is recalling specific lots of Herbert's chow-chow because the firm was manufacturing acidified foods without a license.

    Product
    HERBERT'S chow-chow Mild New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0646-2016·2016-01-20

    Zimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws

    Zimmer Biomet is recalling 400 units of Periarticular Locking Plate System screws because the package labels did not match the product contents.

    Product
    Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0508-2016·2016-01-20

    Snack Depot Recalls Mislabeled Roasted Seasoned Himego Fish Fillets

    Snack Depot, Inc. is recalling 30 cases of Roasted Seasoned Himego Fish because the product was mislabeled and misidentified. The recall is limited to California.

    Product
    Roasted Seasoned Himego Fish Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0649-2016·2016-01-20

    Beckman Coulter Recalls iChem 10 SG Urine Chemistry Strips

    Beckman Coulter is recalling iChem 10 SG Urine Chemistry Strips because they may produce false positive leukocyte results for negative samples.

    Product
    iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0634-2016·2016-01-20

    Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0496-2016·2016-01-20

    Garden Harvest Recalls RJ's Diavolo Sauce for Unlicensed Acidified Food Production

    Garden Harvest is recalling RJ's Diavolo Sauce with Peppers because the firm was manufacturing acidified foods without a license.

    Product
    RJ's DIAVOLO SAUCE WITH PEPPERS 25 oz INGREDIENTS: ground unpeeled vine-ripened tomatoes, tomato puree, tomato past, Hungarian hot wax peppers, Cubanelle peppers, fresh sweet onions, fresh garlic,***Manufactured for: RJ's Pepper Pantry Warren, OH 44484 Phone 330-765-2863 Mild…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0484-2016·2016-01-20

    Garden Harvest Recalls Herbert's Chow-Chow Due to Unlicensed Acidified Food Production

    Garden Harvest is recalling Herbert's chow-chow because the firm was manufacturing acidified foods without a license. The product was distributed to Ohio, Florida, and West Virginia.

    Product
    HERBERT'S chow-chow Original New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0621-2016·2016-01-20

    Boston Scientific Recalls Three Pacemakers Due to Incorrect Literature Packet

    Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.

    Product
    Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0478-2016·2016-01-20

    Garden Harvest Recalls Cafe 422 Hot Peppers in Oil for Unlicensed Manufacturing

    Garden Harvest is recalling 136 cases of Cafe 422 Hot Peppers in Oil because the firm was manufacturing acidified foods without a license. The product was distributed in Ohio, Florida, and West Virginia.

    Product
    Cafe 422 HOT PEPPERS in oil INGREDIENTS Hungarian Hot Peppers***Manufactured & Hand Packed by: Caf¿ 422 4422 Youngstown Rd SE Warren, Ohio 44484 330.369.2422 16 oz UPC 8 60557 00010 2 & 32 oz UPC 8 60557 00011 9
    Category
    Food
    Distribution
    3 states