The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

37151–37175 of 50506

  • HighFDA (Devices)·Z-0281-2016·2015-11-25

    Stryker Recalls PCA Acetabular Inserts Due to Regulatory Omission

    Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.

    Product
    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0272-2016·2015-11-25

    Precision Medical Recalls Easy Dial Oxygen Regulators Due to Label Error

    Precision Medical is recalling 315 Easy Dial Oxygen Regulators because the settings label may be off by one position, causing incorrect oxygen flow.

    Product
    Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Drugs)·D-0349-2016·2015-11-25

    Downing Labs Recalls Taurine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Taurine Injectable, 50mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 123 vials distributed nationwide and internationally.

    Product
    Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2016·2015-11-25

    Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure

    Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.

    Product
    ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 50547  Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0290-2016·2015-11-25

    Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides

    Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0235-2016·2015-11-25

    Kronos Foods Recalls Chocolate Almond Treasure Due to Metal Fragments

    Kronos Foods is recalling Chocolate Almond Treasure because metal fragments were detected after increased metal detector rejections.

    Product
    Chocolate Almond Treasure Net WT 4 lbs. (1.81 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10932 Manufactured by Kronos Foods Corporation, Madera, CA
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0199-2016·2015-11-25

    Certified Smoked Fish Recalls Cold Smoked Salmon Due to Listeria Risk

    Certified Smoked Fish LLC is recalling Cold Smoked Salmon Deli trays in California due to potential Listeria monocytogenes contamination.

    Product
    Cold Smoked Salmon Deli trays (CS300), 2 pcs, 3lbs/trays. 6lbs per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0232-2016·2015-11-25

    Kronos Foods Recalls Classic Baklava Due to Potential Metal Fragments

    Kronos Foods is recalling Classic Baklava because metal fragments were detected during quality control. Consumers should stop eating the product and return it to the store.

    Product
    Classic Baklava; Net WT 5.5 lbs (2.43 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11930 Manufactured by Kronos Foods Corporation, Madera, CA
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0150-2016·2015-11-25

    Kar's Sweet n' Salty Mix Recalled Due to Possible Glass Contamination

    Kar Nut Products Company is recalling Kar's Sweet n' Salty Mix because the product may contain very small pieces of glass.

    Product
    Kar's Sweet n' Salty Mix Box of 18, 3.5 oz. flexible film bags. 1 box per case.
    Category
    Food
    Distribution
    36 states
  • HighFDA (Food)·F-0239-2016·2015-11-25

    Kronos Foods Recalls Orange Blossom Baklava Due to Metal Fragment Risk

    Kronos Foods is recalling Orange Blossom Baklava due to the potential for metal fragments in the baked goods.

    Product
    Orange Blossom Baklava Net WT 5.5 lbs. (249 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11934 Manufactured by Kronos Foods Corporation, Madera, CA
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0208-2016·2015-11-25

    National Frozen Foods Recalls Italian Vegetable Blend for Listeria Risk

    National Frozen Foods Corporation is recalling frozen Italian Vegetable Blend due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***GARDEN FRESH***64775***47374***ITALIAN BLEND CONTAINS: ZUCCHINI, CARROTS, CAULIFLOWER, LIMAS, ITALIAN BEANS***20 LB NET WT***" No UPC on blue liner.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2016·2015-11-25

    Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0200-2016·2015-11-25

    Certified Smoked Fish Recalls Cold Smoked Salmon Trim for Listeria Risk

    Certified Smoked Fish LLC is recalling 13 units of Cold Smoked Salmon Trim in California due to potential Listeria monocytogenes contamination.

    Product
    Cold Smoked Salmon Trim (CST50), 2 pcs, 2.5 lbs/case. 5lbs per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0154-2016·2015-11-25

    Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination

    Kar Nut Products Company is recalling 140,322 bags of Kar's Sweet n' Salty Mix due to the possibility that the product may contain very small pieces of glass.

    Product
    Kar's Sweet n' Salty Mix 3.5 oz. flexible film bags. 42 bags per case.
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0288-2016·2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V797000·2015-11-25

    Newmar Recalls 2016 King Aire Vehicles for Missing Emergency Exit Window

    Newmar is recalling 2016 King Aire vehicles that may lack a required emergency exit window over the driver's side dinette table, potentially delaying escape during an emergency.

    Product
    NEWMAR — NEWMAR KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2016·2015-11-25

    US Compounding Recalls Lincomycin/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,421 vials of Lincomycin/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2016·2015-11-25

    Roche Bulk Loader Module Recalled for Sample Contamination Risk

    Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.

    Product
    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·16044·2015-11-24

    Toro Recalls 2015 TimeCutter Riding Mowers Due to Fire Hazard

    Toro is recalling about 8,600 2015 TimeCutter riding mowers because fuel filters can fracture and leak, posing a fire hazard. No injuries have been reported.

    Product
    2015 Toro TimeCutter Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16042·2015-11-24

    Lutron Recalls Roman Shades Due to Strangulation Hazard

    Lutron Electronics is recalling about 240 custom-made Roman shades sold in the U.S. because exposed tape creates a strangulation risk for children.

    Product
    Roman shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V795000·2015-11-24

    Nissan Recalls GT-R Vehicles for Missing Weight Rating Labels

    Nissan is recalling 2015-2016 GT-R vehicles sold in Puerto Rico because the certification label is missing weight rating information, which could lead to vehicle overloading.

    Product
    NISSAN — NISSAN GT-R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16043·2015-11-24

    Exmark Recalls 2015 Quest Riding Mowers Due to Fire Hazard

    Exmark is recalling about 500 2015 Quest riding mowers because brittle fuel filters can leak fuel, posing a fire hazard. No injuries have been reported.

    Product
    2015 Exmark Quest Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16047·2015-11-24

    MVP Group Recalls Glass Jar Candles Due to Laceration Hazard

    MVP Group is recalling about 720,000 glass jar candles with lids because the glass lids can break when opened, posing a laceration hazard.

    Product
    Glass Jar Candles with Lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide