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.

21426–21450 of 21633

  • ModerateNHTSA·12V367000·2012-07-31

    Keystone Recalls 2013 Bullet Premier Travel Trailers for Labeling Errors

    Keystone RV Company is recalling 220 model year 2013 Bullet Premier 31BHPR travel trailers due to incorrect information on federal identification and tire loading labels.

    Product
    KEYSTONE — KEYSTONE BULLET PREMIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·12V364000·2012-07-30

    Thor Industries Recalls 2013 Crossroads Cruiser Trailers for Labeling Errors

    Thor Industries is recalling 2013 Crossroads Cruiser recreational trailers because incorrect information on federal identification and tire labels may lead to improper loading and tire failure.

    Product
    CROSSROADS — CROSSROADS CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2011-2012·2012-07-25

    Stingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions

    Stingray Surgical Products is recalling bipolar forceps because the Instructions For Use were altered without FDA clearance.

    Product
    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2012·2012-07-25

    Critical Diagnostics Recalls Presage ST2 Assay Kits Due to Inaccurate Results

    Critical Diagnostics is recalling Presage ST2 Assay kits because they may produce inaccurate test results for patients with chronic heart failure.

    Product
    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1993-2012·2012-07-25

    GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.

    Product
    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1767-2012·2012-07-25

    Old Fashioned Foods Recalls Jalapeno Bean Dip Due to Processing Issues

    Old Fashioned Foods is recalling Jalapeno Bean Dip because it was not processed according to FDA regulations for acidified foods.

    Product
    Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrogenated soybean oil, red bell pepper, jalapeno peppers, salt, dehydrated onions, green bell peppers, sorbic acid (as a preservative), vinegar, citric acid, paprika, ,pepper flavor, gallic…
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2029-2012·2012-07-25

    Gulf Fiberoptics Recalls GMF-RC65 Surgical Headlight Cables

    Gulf Fiberoptics, Inc. is recalling 169 GMF-RC65 Replacement Surgical Headlight Cables because the light-transmitting fiber material differs from the approved 510(k) design.

    Product
    GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2012·2012-07-25

    Becton Dickinson Recalls Gram Crystal Violet Stain Reagents

    Becton Dickinson is recalling Gram Crystal Violet 250 mL reagents due to potential artifacts that may interfere with the identification of microorganisms.

    Product
    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2028-2012·2012-07-25

    Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect

    Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.

    Product
    Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2013-2012·2012-07-25

    Abbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes

    Abbott Molecular is recalling the Bar Code Scanner User's Guide because incorrect bar codes may prevent proper language configuration of the scanner.

    Product
    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1418-2012·2012-07-25

    Meda Recalls Prefera OB One Gel Capsules Due to Undeclared Ingredients

    Meda Pharmaceuticals is recalling Prefera OB One Gel Capsules because the product labeling failed to list several inactive ingredients, including D&C Red #33.

    Product
    Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2031-2012·2012-07-25

    Becton Dickinson Recalls BD Gram Stain Kits Due to Staining Artifacts

    Becton Dickinson is recalling 539 BD Gram Stain Kits because increased artifacts may interfere with the distinction between microorganisms.

    Product
    BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2012·2012-07-25

    DeRoyal Recalls Surgical Kits Due to Missing Protective Tape

    DeRoyal Industries is recalling 303 custom surgical kits and trays because clear protective tape was not applied during manufacturing.

    Product
    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2012·2012-07-18

    Philips Recalls Intellispace Portal Software Due to Missing Warning Messages

    Philips is recalling 96 Intellispace Portal software units to fix a defect where the system fails to display a warning message when launching multiple patient studies.

    Product
    Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1740-2012·2012-07-18

    Snyder's-Lance Recalls Tom's Bacon Cheddar Fries for Undeclared Colors

    Snyder's-Lance Inc. is recalling Tom's Bacon Cheddar Fries because the product contains undeclared certified colors.

    Product
    Tom's Bacon Cheddar Fries, Flavored Corn and Potato Snacks, Net Wt., 2.75 oz (78.0g),
    Category
    Food
    Distribution
    22 states
  • ModerateFDA (Food)·F-1743-2012·2012-07-18

    Winter Gardens Maryland Style Crab Soup Recalled for Processing Temperature Issue

    Winter Gardens Quality Foods is recalling Maryland Style Crab Soup due to a possible processing temperature issue during production.

    Product
    Maryland Style Crab Soup 2340 Net Weight 4-4LBS. Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1745-2012·2012-07-18

    Winter Garden Quality Foods Recalls Lobster Bisque Due to Temperature Issue

    Winter Garden Quality Foods is recalling Lobster Bisque because of a possible processing temperature issue during production.

    Product
    Lobster Bisque 3107 Net Weight 4-4 LBS. Keep Refrigerated Packed By Winter Garden Quality Foods, Inc. 304 Commerce St., New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1962-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall for Flow Control Issues

    Terumo is recalling 1,095 units of the Advanced Perfusion System 1 Electronic O2 Blender/Analyzer due to reported difficulty adjusting the local flow control knob.

    Product
    Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2012·2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2012·2012-07-18

    PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps

    PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.

    Product
    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1999-2012·2012-07-18

    PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors

    PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.

    Product
    Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1741-2012·2012-07-18

    Coca-Cola Cherry Zero Recalled for Mislabeling Sugar Content

    Coca-Cola Refreshments USA is recalling 119 cases of Coca Cola Cherry Zero in Texas because the label incorrectly states the product is sugar-free.

    Product
    Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1975-2012·2012-07-18

    Abbott i-Stat Analyzers Recalled for Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Analyzers because they can become uncomfortably hot to touch in the battery area.

    Product
    Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1978-2012·2012-07-18

    Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery Area

    Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch.

    Product
    Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1744-2012·2012-07-18

    Winter Garden Quality Foods Recalls Cream of Crab Soup for Processing Issue

    Winter Garden Quality Foods is recalling specific lots of Cream of Crab Soup due to a possible processing temperature issue during production.

    Product
    FF Cream of Crab Soup 3109 Net Weight 4-4 LB. Keep Refrigerated Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states