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.

24376–24400 of 50442

HighFDA (Devices)·Z-0457-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 80 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide and across the US.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2020·2019-11-27
Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 85 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0449-2020·2019-11-27
Altaire Recalls OCuSOFT Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution because the company cannot guarantee the product is sterile.
Product
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0480-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0416-2020·2019-11-27
Altaire Recalls Altachlore Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling 46,345 units of Altachlore Sodium Chloride Ophthalmic Ointment nationwide due to a lack of assurance of sterility.
Product
ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT — ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0503-2020·2019-11-27
Washington Homeopathic Products Recalls Silicea 6X Tablets for CGMP Deviations
Washington Homeopathic Products, Inc. is recalling 426 bottles of Silicea 6X Tablets because they were not manufactured under current good manufacturing practices.
Product
Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0248-2020·2019-11-27
Del Monte Spicy Pomodoro Linguine Recalled for Listeria Risk
Mann Packing Company is recalling Del Monte Better Break Spicy Pomodoro Linguine due to a Listeria monocytogenes alert. Consumers should check best-by dates and stop eating the product.
Product
Del Monte brand Better Break Spicy Pomodoro; Linguine with Tomato Chipotle Sauce. UPC 717524671004 7 oz. container 6 x 7 oz. per carton
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0433-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 98 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0257-2020·2019-11-27
Mann Packing Recalls Green Beans for Listeria Contamination
Mann Packing Company is recalling various brands of green beans due to a positive test for Listeria monocytogenes. Consumers should check their pantries for the affected products.
Product
Green Beans: 12 oz. UPC 11110016645 Kroger Organic 12 oz. UPC: 68820106258 Compliments - Canada HEB Brand: 12 oz. UPC: 41220176083 32 oz. UPC: 41220903191 Mann's Organic: 10 oz. UPC: 716519049996 Mann's Family Favorites 24 oz. UPC: 716519045158 - US and…
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0419-2020·2019-11-27
Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk
Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.
Product
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2020·2019-11-27
Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2020·2019-11-27
Cook Torcon NB Advantage Catheters Recalled for Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0430-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and in the US.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2020·2019-11-27
Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems
Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.
Product
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 25 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The products were distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0432-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 1,125 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0373-2020·2019-11-27
CVS Health Natural Tears Lubricant Eye Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling CVS Health Natural Tears Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 152,369 units distributed nationwide.
Product
CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2020·2019-11-27
BD Posiflush Syringes Recalled Due to Experimental Product Mix-Up
Becton Dickinson is recalling BD Posiflush syringes because a limited number of experimental units were mixed with standard products.
Product
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide