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.

20701–20725 of 21633

  • ModerateFDA (Drugs)·D-204-2013·2013-03-27

    Watson Recalls Meprobamate Tablets Due to Impurity Failure

    Watson Laboratories is recalling meprobamate 400 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

    Product
    Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-205-2013·2013-03-27

    Watson Recalls Zarah Oral Contraceptive Tablets Due to Breakage

    Watson Laboratories is recalling Zarah oral contraceptive tablets because they may break while being pushed through the blister pack.

    Product
    ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1244-2013·2013-03-27

    Wynlife Recalls Probiotics and Vegi-Fiber Plus Due to DEHP Contamination

    Wynlife Healthcare is recalling All-In-One Probiotics and Vegi-Fiber Plus products because they contain DEHP-contaminated clouding agents.

    Product
    All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0973-2013·2013-03-27

    Keystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants

    Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implants because the included cover screw was a WD type instead of the labeled SD type.

    Product
    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0964-2013·2013-03-27

    Stryker Specialty Triathlon Knee Sizer Adjustment Housing Recalled for Fit and Marking Errors

    Stryker is recalling four units of Specialty Triathlon Knee Sizer Adjustment Housings because the standard femoral stylus does not fit and the left/right markings on the right sizer are reversed.

    Product
    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1243-2013·2013-03-27

    Wynlife Recalls Vegi-Fiber Plus and Probiotics Due to DEHP Contamination

    Wynlife Healthcare is recalling Vegi-Fiber Plus and All-In-One Probiotics because they contain DEHP-contaminated clouding agents.

    Product
    Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1246-2013·2013-03-27

    Great Value Salsa Mild Recalled for Potential Plastic Contamination

    Conagra is recalling Great Value Salsa Mild because the product may contain plastic pieces. Consumers should stop using the product.

    Product
    Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0956-2013·2013-03-27

    Synthes Recalls Four Mis-etched Variable Angle Locking Compression Plates

    Synthes USA is recalling four Variable Angle Locking Compression Plates that were incorrectly etched with the wrong part number.

    Product
    Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1245-2013·2013-03-27

    Conagra Recalls Great Value Salsa Due to Potential Plastic Contamination

    Conagra Inc is recalling Great Value All Natural Mild Chunky Salsa because the product may contain plastic pieces.

    Product
    Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0958-2013·2013-03-27

    Beckman Coulter Recalls Creatinine Reagents for Calibration Instructions

    Beckman Coulter is recalling Creatinine reagents to provide updated instructions for calibration stability and quality control frequency.

    Product
    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2013·2013-03-27

    Alphatec ILLICO Spinal Rods Recalled for Incorrect Length Marking

    Alphatec Spine is recalling 7 ILLICO spinal rods that were laser-etched as 110mm but are actually 100mm long.

    Product
    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0957-2013·2013-03-27

    Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery

    Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.

    Product
    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0922-2013·2013-03-20

    Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues

    Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.

    Product
    Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0938-2013·2013-03-20

    Synthes Spine Pedicle Screw Recalled for Incorrect Length Etching

    Synthes USA HQ, Inc. is recalling 18 units of 45 mm Click 'X Pedicle Screws because they were incorrectly etched as 40 mm.

    Product
    Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-1195-2013·2013-03-20

    King Arthur Flour Recalled Nationwide Due to Foreign Material Contamination

    The King Arthur Flour Company is recalling specific lots of 5-lb. Unbleached All-Purpose Flour nationwide because of foreign material contamination.

    Product
    King Arthur Unbleached All-Purpose Flour, 5-lb. bag UPC 0-71012-01050-9
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2013·2013-03-20

    Spine Smith Partners Recalls Cynch Lordotic T-PLIF Implants Due to Marking Error

    Spine Smith Partners LP is recalling three Cynch Lordotic T-PLIF implants distributed in Texas because they were incorrectly laser marked as 23mm instead of 28mm.

    Product
    Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0951-2013·2013-03-20

    Diagnostica Stago Recalls LIATEST VWF:Ag Coagulation Assay Kits

    Diagnostica Stago is recalling LIATEST VWF:Ag kits because measurement errors may lead to lowered percentage results.

    Product
    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0941-2013·2013-03-20

    Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts

    Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.

    Product
    Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0950-2013·2013-03-20

    Philips Brilliance 64 and Ingenuity CT Systems Software Update Recall

    Philips Medical Systems is recalling 42 Brilliance 64 and Ingenuity CT systems to update software and customer release notes.

    Product
    Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-1196-2013·2013-03-20

    King Arthur Unbleached Bread Flour Recalled for Foreign Material

    The King Arthur Flour Company is voluntarily recalling 5-lb bags of Unbleached Bread Flour nationwide due to the presence of foreign material.

    Product
    King Arthur Unbleached Bread Flour, 5-lb. bag UPC 0-71012-04105-3
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1067-2013·2013-03-20

    Yoruk Prens Rosehip Drink Mix Recalled for Unauthorized Colorants

    Ethnic International Holding Inc. is recalling Yoruk Prens Rosehip Drink Mix because it contains colorants not allowed in the USA.

    Product
    ROSEHIP DRINK MIX. Yoruk Prens Tarcin Kusburnu Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of flower on label.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0942-2013·2013-03-20

    Synthes Titanium Midface Distractor Recalled Due to Fit Issues

    Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.

    Product
    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0935-2013·2013-03-20

    GE Healthcare Recalls MRI Systems Due to Reporting Tool Error

    GE Healthcare is recalling multiple MRI systems because an error in the SR Viewer Reporting Tool allows edits to be saved to incorrect reports.

    Product
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0937-2013·2013-03-20

    Vygon Recalls 210 CT PICC Kits Packaged with Incorrect Needles

    Vygon Corporation is recalling 210 units of 6F Triple Lumen CT PICC kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.

    Product
    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
    Category
    Medical Device
    Distribution
    1 state