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.

24201–24225 of 50442

  • HighFDA (Devices)·Z-0688-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0401-2020·2019-12-25

    Whole Foods Recalls Chicken Orange and Vegetable Meals for Listeria Risk

    Whole Foods Market is recalling Family Meal Chicken Orange and Vegetable products due to possible contamination with Listeria monocytogenes.

    Product
    Family Meal Chicken Orange and Vegetable UPC 22849900000 sold packaged in stores, PLU 28499
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0383-2020·2019-12-25

    Whole Foods Recalls Salmon Dinner with Mild Italian for Listeria Risk

    Whole Foods Market is recalling Salmon Dinner with Mild Italian for 2 due to possible contamination with Listeria monocytogenes.

    Product
    Salmon Dinner with Mild Italian for 2 packaged in the store UPC 20451300000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0354-2020·2019-12-25

    Whole Foods Recalls Wedge Greek Salad for Listeria Risk

    Whole Foods Market is recalling Wedge Greek Salad served on the salad bar due to possible contamination with Listeria monocytogenes.

    Product
    Wedge Greek Salad served on the salad bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2020·2019-12-25

    AuroMedics Recalls Gabapentin Capsules Due to Foreign Tablet Presence

    AuroMedics Pharma LLC is recalling specific lots of Gabapentin Capsules because a Losartan/HCTZ tablet was found in the bottles.

    Product
    Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2020·2019-12-25

    Whole Foods Recalls Salmon Dinner with Lemon Herb for Listeria Risk

    Whole Foods Market is recalling Salmon Dinner with Lemon Herb for 2 due to possible contamination with Listeria monocytogenes.

    Product
    Salmon Dinner with Lemon Herb for 2 packaged in the store UPC 20451100000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2020·2019-12-25

    GE Healthcare Recalls Aespire and Aestiva Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling Aespire and Aestiva anesthesia systems due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2020·2019-12-25

    Smith & Nephew Recalls PROFIX Mallets Due to Tip Detachment Risk

    Smith & Nephew is recalling 1,371 PROFIX Mallets because the poly tip may detach during surgery, potentially releasing particles into the surgical field.

    Product
    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0337-2020·2019-12-25

    Gold Standard Baking Recalls Croissants Due to Missing Allergen Labels

    Gold Standard Baking is recalling Freshness Guaranteed Croissants because the packaging is missing ingredient and nutrition labels, including required allergen information for milk, wheat, and soy.

    Product
    Freshness Guaranteed Croissants in clear plastic 12oz clamshell, 12 clamshells per case, item number 7012
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep single-use cups due to potential contamination with Burkholderia cepacia. The product is distributed in six US states.

    Product
    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7900 Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling 7,168 Aestiva 7900 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7100 Anesthesia Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 473 Aestiva 7100 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2020·2019-12-25

    NxStage Low Volume Cartridge Recalled for Hemodialysis Risk

    NxStage Medical is recalling Low Volume Cartridge IFUs due to a potential health risk for low-volume patients using larger dialysate volumes.

    Product
    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0346-2020·2019-12-25

    Hodgson Mill White Wheat Flour Recalled for E. coli Contamination Risk

    FDA is recalling Hodgson Mill Unbleached All-Purpose White Wheat Flour due to potential contamination with Shiga toxin-producing E. coli (STEC). Consumers should stop using the affected 5 lb bags.

    Product
    Hodgson Mill Unbleached All-Purpose White Wheat Flour 5 Lb bags 001042 Best By 10-01-2020 005517 Best By 10-02-2020
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0356-2020·2019-12-25

    Whole Foods Recalls Roasted Cauliflower Salad Bar Item for Listeria Risk

    Whole Foods Market is recalling Caulilini, Roasted with Roasted Garlic, served on the salad bar, due to possible contamination with Listeria monocytogenes.

    Product
    Caulilini, Roasted with Roasted Garlic served on the salad bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Electroconductive Cream

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep electroconductive cream due to potential contamination with Burkholderia cepacia.

    Product
    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V912000·2019-12-20

    BMW Recalls 2019-2020 330i Models Due to Rear Seat Belt Defect

    BMW is recalling 2019-2020 330i and 330i xDrive vehicles because the outboard rear seat belt pretensioners may not lock during a crash, increasing injury risk.

    Product
    BMW — BMW 330I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20046·2019-12-20

    Bosch Recalls Buderus GB125-35 Boilers Due to Carbon Monoxide Hazard

    Bosch Thermotechnology is recalling Buderus GB125-35 oil-condensing boilers because a blocked siphon can cause delayed ignition and carbon monoxide release. No injuries have been reported in the U.S.

    Product
    Buderus GB125-35 oil-condensing boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide