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.

11651–11675 of 21617

  • ModerateFDA (Devices)·Z-0233-2018·2017-12-20

    Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons

    Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.

    Product
    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2018·2017-12-20

    United Nuclear Scientific Recalls Three High Power Handheld Lasers

    United Nuclear Scientific Supplies, LLC is recalling three high power handheld laser products for failing to comply with laser class limitations.

    Product
    United Nuclear Scientific High Power Handheld Lasers. Laser products
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0215-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0186-2018·2017-12-20

    Physio-Control Recalls Defibrillation Electrodes Due to Incorrect Pad Placement Artwork

    Physio-Control is recalling 14,219 LIFEPAK defibrillation electrodes because the artwork instructs incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0187-2018·2017-12-20

    Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors

    Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V828000·2017-12-18

    Mercedes-Benz Recalls GLE 550e Vehicles for Incorrect Tire Pressure Labels

    Mercedes-Benz is recalling 2016-2017 GLE 550e 4MATIC vehicles because the B-pillar tire pressure label lists incorrect seating capacity and tire dimensions, violating federal safety standards.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE550E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0451-2018·2017-12-13

    Krispy Kreme Recalls Glazed Mini Crullers Due to Foreign Matter

    Krispy Kreme is recalling Glazed Mini Crullers because a foreign matter was found on the product. The recall affects 4,041 boxes and containers distributed in Georgia and South Carolina.

    Product
    Krispy Kreme Doughnuts, Glazed Mini Crullers, Krispy Juniors, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0453-2018·2017-12-13

    Krispy Kreme Doughnut Holes Recalled for Foreign Matter Contamination

    Krispy Kreme is recalling Original Glazed Doughnut Holes because a foreign matter strand was found in the product. The recall affects boxes sold in Georgia and South Carolina.

    Product
    Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0449-2018·2017-12-13

    Krispy Kreme Pumpkin Spice Doughnuts Recalled for Foreign Matter

    Krispy Kreme is recalling Glazed Pumpkin Spice Cake Doughnuts because a foreign matter strand was found in the product. The recall affects 4,041 boxes sold in Georgia and South Carolina.

    Product
    Krispy Kreme Doughnuts, Glazed Pumpkin Spice Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0440-2018·2017-12-13

    JP's Delicacies Recalls Holi Aioli Lemon Basil Bottles

    JP's Delicacies LLC is recalling 1,344 bottles of Holi Aioli, Lemon Basil, 12oz, due to bulging bottles found during store inspections.

    Product
    Holi Aioli, Lemon Basil 12oz bottle
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0493-2018·2017-12-13

    Kroger Recalls Comforts FOR BABY Purified Water Due to Mold Complaint

    The Kroger Co. is recalling Comforts FOR BABY Purified Water with Fluoride Added after a complaint of mold was found in the product.

    Product
    Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-0435-2018·2017-12-13

    Donkey Salsa Recalls Salsa Not Hot Due to Plastic Contamination

    Donkey Salsa is recalling Salsa Not Hot 15 oz jars because they may contain pieces of plastic. The product was distributed in New York.

    Product
    SALSA NOT HOT Net Wt. 15 oz (426G)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0211-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2018·2017-12-13

    Biosense Webster Recalls PENTARAY NAV Mapping Catheters Due to Labeling Update

    Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.

    Product
    PENTARAY NAV High-Density Mapping Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0448-2018·2017-12-13

    Krispy Kreme Original Glazed Doughnuts Recalled for Foreign Matter

    Krispy Kreme is recalling Original Glazed Doughnuts because a foreign matter strand was found on the product. The recall affects 4,041 boxes and containers distributed in Georgia and South Carolina.

    Product
    Krispy Kreme Doughnuts, Original Glazed Doughnuts, Net Wt. 9.4oz (half dozen) and Net Wt. 18.7oz (one dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0199-2018·2017-12-13

    DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads

    DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.

    Product
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0203-2018·2017-12-13

    Fukuda Denshi Patient Monitor Recall for Damaged Lithium-Ion Capacitor

    Fukuda Denshi is recalling DS-8100M and DS-8100N patient monitors because a damaged lithium-ion capacitor may cause a short-term battery error message.

    Product
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be requi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0204-2018·2017-12-13

    FDA Recalls Two Unapproved Morning Life Air Compression Devices

    Won Industry Co. is recalling two Morning Life air compression devices because they were distributed without FDA approval and have incorrect air compression settings.

    Product
    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2018·2017-12-13

    Remel Mueller-Hinton Broth Recalled for Incorrect Cation Labeling

    Remel Inc is recalling 7 units of Mueller-Hinton Broth IVD because the product label may contain incorrect cation information.

    Product
    CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0107-2018·2017-12-13

    Elite Laboratories Recalls Isradapine Capsules Due to Impurity Failures

    Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg in New York due to failed impurities and degradation specifications.

    Product
    Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0206-2018·2017-12-13

    Novo Nordisk Recalls Dial-A-Dose Insulin Pen Cartridge Holders

    Novo Nordisk is recalling specific batches of Dial-A-Dose insulin pen cartridge holders because they may crack or break when exposed to certain cleaning agents.

    Product
    Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0452-2018·2017-12-13

    Krispy Kreme Doughnuts Recalled for Foreign Matter Contamination

    Krispy Kreme is recalling specific lots of doughnuts and doughnut holes found with a foreign strand. Consumers in Georgia and South Carolina should discard these products.

    Product
    Krispy Kreme Doughnuts, Glazed Cake, Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0450-2018·2017-12-13

    Krispy Kreme Glazed Mini Crullers Recalled for Foreign Matter

    Krispy Kreme is recalling Glazed Mini Crullers because a foreign strand was found in the product. The recall affects 4,041 boxes sold in Georgia and South Carolina.

    Product
    Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102.
    Category
    Food
    Distribution
    2 states