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.

21401–21425 of 21633

  • ModerateFDA (Food)·F-1817-2012·2012-08-08

    Aloha Maid Natural Coconut Water with Pineapple Recalled for Off-Smell and Taste

    Itoen (USA) Inc. is recalling Aloha Maid Natural Coconut Water with Pineapple cans in Hawaii due to off-smell and off-taste.

    Product
    Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1437-2012·2012-08-08

    West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.

    Product
    FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1773·2012-08-01

    21st Century Foods Soy Tempeh Recalled for Coliforms

    21st Century Foods is recalling Soy Tempeh in 12 lb bags and 8 oz containers because testing found coliforms. The product was distributed in Connecticut and Massachusetts.

    Product
    21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2086-2012·2012-08-01

    Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2012·2012-08-01

    Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions

    Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2012·2012-08-01

    Beekley Bella Blanket Mammography Coverlet Recalled for Imaging Artifacts

    Beekley Corporation is recalling Bella Blanket Protective Coverlets used in mammography because they can cause imaging artifacts on results.

    Product
    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2012·2012-08-01

    Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2012·2012-08-01

    Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2012·2012-08-01

    Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes

    Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.

    Product
    The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1795-2012·2012-08-01

    Atlapac Trading Company Recalls California Girl Whole Boiled Oysters

    Atlapac Trading Company Inc is recalling 880 cases of California Girl Whole Boiled Oysters due to potential contamination from insanitary conditions.

    Product
    "California Girl" Whole Boiled Oysters, 24/8 oz cans.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2054-2012·2012-08-01

    Synthes Universal Spinal System Lamina Hooks Recalled for Incorrect Etching

    Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks because they are etched with the wrong part number.

    Product
    Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2012·2012-08-01

    Exactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components

    Exactech is recalling 12 Optetrak tibial trays because they have the potential to be mislabeled. The affected trays were distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2069-2012·2012-08-01

    AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display

    AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed reports.

    Product
    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2012·2012-08-01

    Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction

    Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.

    Product
    Siemens syngo.plaza. Radiological image processing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2012·2012-08-01

    Leica M525 F50 Surgical Microscope Recalled for Illumination Malfunction

    Leica Microsystems is recalling M525 F50 surgical microscopes because a malfunction can cause reduced illumination when used with specific remote control adapters.

    Product
    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2060-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling two lots of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1804-2012·2012-08-01

    Meiko Cooked Cuttlefish Ball Recalled for Lack of HACCP Plan

    Meiko Foods is recalling cooked cuttlefish balls because they were processed without a HACCP plan to control known hazards.

    Product
    Meiko Foods Co. Inc. Cooked Cuttlefish Ball, 2-10 lb bags . Product labeling reads in part:" MEIKO***Muc Vien [Vietnamese] ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1797-2012·2012-08-01

    Plenus Group Recalls New England Clam Chowder Due to Processing Issue

    Plenus Group Inc. is recalling 287 cases of 8-pound refrigerated New England Clam Chowder in four states because the product was under processed.

    Product
    New England Clam Chowda, pouch 8 lbs., refrigerated. For Institutional Use Only. Mfd. by Plenus Group, Inc., Lowell, MA 01852 Product Number 1023 UPC #: 7 3051691023 3
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1798-2012·2012-08-01

    Plenus Group Recalls New England Clam Chowda Base

    Plenus Group Inc. is recalling 13 cases of New England Clam Chowda Base due to a processing issue. The product was distributed in four New England states.

    Product
    New England Clam Chowda Base, pouch 4 lbs., refrigerated. For Institutional Use Only. Mfd. by Plenus Group, Inc., Lowell, MA 01852 Product Number 1010 UPC #: 7 3051691010 3
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1790-2012·2012-08-01

    Duane Reade Recalls Pediatric Oral Electrolyte Solution for Deficient Sodium and Potassium

    Duane Reade is recalling Pediatric Oral Electrolyte Solution in Fruit Punch flavor due to deficient sodium and potassium content. The product was distributed in New York and New Jersey.

    Product
    Pediatric electrolyte, Fruit Punch flavor---oral electrolyte solution---helps replace fluids & electrolytes---8 FL OZ (236 mL)---UPC Code: 31191129235 Distributed by Duane Reade/(866)375-6925---440 Ninth Ave., NY, NY 10001---Item #51070-8-4-
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2084-2012·2012-08-01

    Stryker Recalls Tibial Punch Tower Assembly Due to Undersized Slot

    Stryker Howmedica Osteonics is recalling 152 units of Tibial Punch Tower Assemblies because an undersized slot may prevent keel punches from being inserted.

    Product
    Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2057-2012·2012-08-01

    OrthoPediatrics PediLoc Locking Plate System Recalled for Incorrect Left-Right Labeling

    OrthoPediatrics Corp is recalling 15 PediLoc Locking Plate System devices because they are left-sided plates incorrectly labeled and etched as right-sided.

    Product
    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2070-2012·2012-08-01

    Exactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components

    Exactech is recalling specific Optetrak knee replacement trays because they may be mislabeled. The recall covers 16 units distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2079-2012·2012-08-01

    Getinge 9100-Series Washer Disinfectors Recalled for Ground Fault Breaker Error

    Getinge USA Inc is voluntarily recalling 8 large capacity washer disinfectors due to a production error in the ground fault breaker.

    Product
    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils.…
    Category
    Medical Device
    Distribution
    5 states