The Recall Desk

Hazard

Product Defect recalls

130 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
130
Critical
1
Severe
14
Most recent
2026-08-26

Of the 130 product defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (11%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all product defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–125 of 130

  • LowFDA (Devices)·Z-0666-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling Heliomolar Refill units because the material was reported to be too soft and sticky, causing handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3078-2017·2017-09-06

    Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk

    Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.

    Product
    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0425-2017·2017-01-18

    Baxter Recalls Premasol Sulfite-Free Amino Acid Injection Due to Discoloration

    Baxter Healthcare is recalling 3,528 units of Premasol Sulfite-Free Amino Acid Injection due to yellow discoloration caused by a damaged overpouch.

    Product
    PREMASOL - SULFITE-FREE (AMINO ACID) — PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0384-2017·2016-12-28

    Teleflex Medical Recalls LMA MADgic Atomization Devices for Spray Defect

    Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2017·2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Short Sprayers for Anesthesia Delivery

    Teleflex Medical is recalling Flexi Nozzle Short sprayers because they may deliver a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully ato
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2017·2016-12-21

    Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects

    Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.

    Product
    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Drugs)·D-1465-2016·2016-08-31

    Exact-Rx Recalls Urea Cream Due to Crystallization

    Exact-Rx Inc. is recalling specific lots of Urea (50% Urea in a Cream Base) because crystals formed in the product.

    Product
    Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2016·2016-07-06

    Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks

    Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.

    Product
    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1294-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.

    Product
    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-1297-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • LowFDA (Devices)·Z-2764-2015·2015-09-23

    Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals

    Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.

    Product
    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits:
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1242-2015·2015-07-22

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injection due to the presence of crystals identified as the calcium salt of Ketorolac.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2015·2014-12-31

    Radiometer HemoCue Glucose 201 Microcuvettes Recalled for Discoloration and Inaccurate Results

    Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0016-2014·2014-10-22

    Avella Recalls Hydroxyprogesterone Caproate Injectable Due to Crystallization

    Avella of Deer Valley, Inc. is recalling 197 vials of Hydroxyprogesterone Caproate 250 mg/mL injectable because crystals were observed in the product.

    Product
    HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1352-2014·2014-06-04

    PediaCare Nighttime Cold Syrup Recalled for Diphenhydramine Precipitate

    Prestige Brands Holdings is recalling PediaCare Nighttime Multi-Symptom Cold syrup due to the presence of diphenhydramine precipitate in the solution.

    Product
    PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1298-2014·2014-05-07

    P&L Developments Recalls Children's Cold and Cough Liquid for Precipitate

    P&L Developments is recalling 1,363,338 bottles of Children's Triacting Night Time Cold & Cough with PE because small amounts of diphenhydramine and mannitol precipitated out of solution.

    Product
    Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) F
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1097-2014·2014-03-12

    Aaron Industries Recalls Tussin CF Cold Liquid Due to Precipitate

    Aaron Industries is recalling Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid due to the presence of a white precipitate, confirmed to be the active ingredient guaifenesin.

    Product
    Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1111-2014·2014-03-05

    Roche Recalls Leaking cobas PCR Urine and Swab Test Kits

    Roche Molecular Systems is recalling 84 batches of cobas PCR Urine, Female Swab, and media kits due to reports of leaking media.

    Product
    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-392-2014·2014-01-08

    Teva Recalls Daunorubicin Hydrochloride Injection Due to Precipitate Presence

    Teva Pharmaceuticals USA is recalling specific lots of Daunorubicin Hydrochloride Injection because the drug product contains precipitate.

    Product
    Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0028-2014·2013-10-30

    Chobani Champions Greek Yogurt Tubes Recalled Due to Illness Reports

    Chobani Champions Greek yogurt tubes are being recalled because of reported illnesses and product swelling. Consumers should stop using the affected products.

    Product
    Chobani Champions tubes, 2.25 oz., are sold in packages of 8, 16, or 36 counts per packages: 6/36/2.25 oz. Champions 1.5% Milkfat Low-Fat Greek Yogurt Rockin Blueberry & Jammin Strawberry-Tubes Variety Pack, UPC 8-18290-01230-2 6/16/2.25 oz. Champions 1.5% Milkfat Low-Fat G
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2013·2013-08-21

    SpineFrontier Recalls Surgical Case Lids and Bases Due to Ink Delamination

    SpineFrontier, Inc. is recalling specific surgical case lids and bases because non-toxic inks used on the graphics are delaminating or running off after repeated washing and sterilization cycles.

    Product
    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0676-2013·2013-01-23

    Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2012·2012-09-12

    BD GeneOhm Cdiff Assay Recalled Due to Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay because of leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2012·2012-09-12

    Breg Polar Dressing Recalled for Thickness and Durability Defects

    Breg Inc. is recalling Polar Dressing units that are thinner than specified, making them less durable and prone to tearing.

    Product
    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide