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.

36901–36925 of 50506

  • HighFDA (Drugs)·D-0551-2016·2016-01-06

    Walgreens Recalls Nafcillin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 7 bags of Nafcillin 12 gm in NS 500 mL due to a lack of assurance of sterility. The product was distributed in Texas.

    Product
    Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0560-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0554-2016·2016-01-06

    Walgreens Recalls Cefepime Infusion Minibags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 26 minibags of Cefepime 1 g/NS 100 mL due to a lack of assurance of sterility. The product was distributed in Texas.

    Product
    Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0461-2016·2016-01-06

    Barilla Penne Recalled for Aluminum Fragments in Club Store Packaging

    Barilla America NY, Inc. is recalling specific lots of Penne pasta due to the presence of aluminum fragments.

    Product
    Barilla PENNE, 8 X 1 LB (454 g) BOXES, [NET WT. 8 LB (3.63 kg)], GTIN 10076808034360, packed as a Multi-unit box, 8 units per case for sale at club stores.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0459-2016·2016-01-06

    Barilla Recalls Four Pasta Types Due to Aluminum Fragments

    Barilla America NY, Inc. is recalling four types of pasta, including Barilla Pronto PENNE, due to the presence of aluminum fragments.

    Product
    Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0527-2016·2016-01-06

    Walgreens Recalls Heparin Injection Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 49 syringes of Heparin injection, Preservative Free, due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0558-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives

    Beckman Coulter is recalling MicroScan Pos Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0546-2016·2016-01-06

    Walgreens Recalls Famotidine Injection Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 21 famotidine injection syringes compounded by Option Care 148 in Texas due to a lack of assurance of sterility.

    Product
    Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0434-2016·2016-01-06

    Simply Enjoy Shrimp and Lobster Ravioli Recalled for Ingredient Mislabeling

    Nuovo Pasta Productions is recalling Simply Enjoy Shrimp and Lobster Ravioli because the packaging incorrectly lists ingredients for a different product.

    Product
    Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD. UPC Code: 68826743926
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0529-2016·2016-01-06

    Walgreens Recalls Piperacillin/Tazobactam Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 26 bags of Piperacillin/Tazobactam (Zosyn) Accuflo in Texas due to a lack of assurance of sterility.

    Product
    Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0571-2016·2016-01-06

    BD Vacutainer K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16719·2016-01-05

    KTM Recalls Competition Off-Road Motorcycles Due to Fuel Hose Fire Hazard

    KTM North America is recalling about 1,800 competition off-road motorcycles because molded fuel hoses could leak fuel, posing a fire hazard. No injuries have been reported.

    Product
    Competition Off-road Motocross Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V003000·2016-01-05

    Foretravel Recalls 2008 Nimbus Motorhomes Due to Unstable Entry Steps

    Foretravel is recalling 2008 Nimbus motorhomes because a bolt on the electric entry steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    FORETRAVEL — FORETRAVEL NIMBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V001000·2016-01-04

    AEV Ambulance Wheelchair Van Recall for Lift Bearing Defect

    Halcore is recalling 2006-2013 AEV Ambulance Wheelchair Vans because wheelchair lift bearings may move, causing the platform to fall and injure operators.

    Product
    AEV — AEV AMBULANCE WHEELCHAIR VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V890000·2015-12-31

    Compass Recalls Horse Trailers with Defective Water Heaters

    Compass Conversions is recalling specific 2014 and 2015 horse trailers due to a gas valve defect that may cause water to overheat, posing a scalding risk.

    Product
    PLATINUM — PLATINUM, BLOOMER HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·150-2015·2015-12-31

    Jafflz Sandwiches Recalled Due to Cooling Process Deviation

    Du Monde Gourmet is recalling Jafflz pocket sandwiches due to a possible cooling process deviation that could allow harmful bacteria to grow.

    Product
    Jafflz LLC — Du Monde Gourmet Recalls Jafflz Sandwich Products Due To Possible Cooling/Process Deviation
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0475-2016·2015-12-30

    Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure

    Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.

    Product
    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0463-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2016·2015-12-30

    Hardy Diagnostics Recalls FB Broth Due to Potential Contamination

    Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.

    Product
    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0460-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.

    Product
    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2016·2015-12-30

    Airways Development Recalls WaterPAP Positive Airway Pressure Devices

    Airways Development LLC is recalling 1,464 WaterPAP Positive Airway Pressure Devices due to a reported canister leak.

    Product
    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Safety Hazard

    Siemens is recalling 151 Reagent Management System units because missing safety covers expose electrical termination blocks, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide