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.

32551–32575 of 50502

HighFDA (Devices)·Z-1772-2017·2017-04-19
Draeger Medical Systems Recalls Delta Patient Monitors Due to Low Oxygen Alarm Failure
Draeger Medical Systems is recalling Delta patient monitors used with Scio gas modules because the low oxygen alarm may fail to sound when oxygen levels drop below the set limit.
Product
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1920-2017·2017-04-19
J&J Distributing Recalls Salad Super Kale Due to Metal Contamination
J&J Distributing Company is recalling Kowalski's Markets Salad Super Kale because shred carrots used as an ingredient were contaminated with metal pieces.
Product
Kowalski's Markets, Salad Super Kale, UPC 6-10014-14316-9, 9 oz in plastic container.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1800-2017·2017-04-19
Windstone Medical Vitrectomy Packs Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling 100 Vitrectomy Packs because the sterile packaging of the included eye pads may be compromised.
Product
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1934-2017·2017-04-19
Dolcetta Artisan Sweets Recalls Hazelnut Truffles Due to Undeclared Soy Lecithin
Dolcetta Artisan Sweets is recalling 180 boxes of Hazelnut Truffles distributed in Oregon and Washington because the product contains undeclared soy lecithin.
Product
Hazelnut Truffles are dark chocolate with hazelnut ganache, 3.9 oz (110g), individually wrapped in clear cellophane and then wrapped in a paper box.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1921-2017·2017-04-19
J & J Distributing Recalls Rainbow Coleslaw Due to Metal Contamination
J & J Distributing Company is recalling Rainbow Coleslaw because shredded carrots used as an ingredient were contaminated with metal pieces.
Product
Rainbow Coleslaw, 5 lbs for Food Service (Franchise) in Food service plastic bag.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1941-2017·2017-04-19
Dolcetta Peanut Crisp Truffles Recalled for Undeclared Soy Lecithin
Dolcetta Artisan Sweets is recalling Peanut Crisp Truffles because the product contains undeclared soy lecithin, a potential allergen.
Product
Peanut Crisp Truffles are milk chocolate with peanut butter truffles, 3.9 oz (110g), individually wrapped in clear cellophane and then wrapped in a paper box. The label declared "***Peanut Crisp Truffles***49% milk chocolate, peanut butter, feuilletine (wheat), cocoa powder…
Category
Food
Distribution
2 states
HighFDA (Food)·F-1879-2017·2017-04-19
Braised Bamboo Shoots Recalled for Undeclared Wheat Allergen
Companion Foods Corp. is recalling Braised Bamboo Shoot Tips with Chili because an FDA inspection found wheat was not properly declared in the ingredient list.
Product
BRAISED BAMBOO SHOOT TIPS WITH CHILI, 10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10058 3 Companion Foods Corp. Taipei, Taiwan
Category
Food
Distribution
3 states
HighFDA (Food)·F-1940-2017·2017-04-19
Dolcetta Artisan Sweets Recalls Milk Chocolate Pretzel Bars for Undeclared Allergens
Dolcetta Artisan Sweets is recalling 400 Milk Chocolate Pretzel Bars distributed in Oregon and Washington due to undeclared soy lecithin and wheat.
Product
Milk Chocolate Pretzel Bar, net wt. 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box. The label declared: "***Milk Chocolate Pretzel Bar*** 49% milk chocolate, pretzels, butter, sea salt, baking soda***".
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1778-2017·2017-04-19
Merge Hemo software recall for incorrect FFR results display
Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.
Product
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2017·2017-04-19
Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise
Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.
Product
Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1788-2017·2017-04-19
Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.
Product
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1801-2017·2017-04-19
BioMerieux Recalls VIDAS Estradiol II Assay Due to Fulvestrant Cross-Reactivity
BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.
Product
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1922-2017·2017-04-19
Gerber Pasta Pick-Ups Cheese Ravioli Recalled for Missing Egg Allergen Label
Gerber is recalling Pasta Pick-Ups Cheese Ravioli because the egg allergen is missing from the 'Contains' statement on the packaging.
Product
Gerber¿ Pasta Pick-Ups Cheese Ravioli Net Wt 6 oz (170g) Drained Wt 3 oz (85g) UPC 01500000907-6 , Truncated - written on package as: UPC 159070
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1917-2017·2017-04-19
Kowalski's Markets Carrot and Vegetable Wraps Recalled for Metal Contamination
J & J Distributing Company is recalling Kowalski's Markets Carrot, Apple, Hummus Wraps and Vegetable Wraps because shredded carrots used in the products were contaminated with metal pieces.
Product
Kowalski's Markets, Carrot, Apple, Hummus Wrap UPC 6-10014-09915-2 & Vegetable Wrap UPC 6-10014-08723-4 , 11 oz in plastic container.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1787-2017·2017-04-19
Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.
Product
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1931-2017·2017-04-19
Dolcetta Dark Chocolate Toffee Santa Recalled for Undeclared Soy Lecithin
Dolcetta Artisan Sweets is recalling 20 boxes of Dark Chocolate Toffee Santa because the product contains undeclared soy lecithin.
Product
Dark Chocolate Toffee Santa, dark chocolate with bits of toffee, 150g (5.3 oz), the product is packaged in a clear plastic box.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1794-2017·2017-04-19
Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Product
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1799-2017·2017-04-19
Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Product
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2017·2017-04-19
ConMed Recalls Sterile Handpiece Sheaths Packaged in Error
ConMed is recalling sterile handpiece sheaths that were packaged in error with non-sterile units. The mislabeling could lead to the use of non-sterile sheaths.
Product
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1944-2017·2017-04-19
Dolcetta Salted Caramel Bonbons Recalled for Undeclared Soy Lecithin
Dolcetta Artisan Sweets is recalling Salted Caramel Bonbons because the product contains undeclared soy lecithin, a major food allergen.
Product
Salted Caramel Bonbons are molded chocolate shells filled with salted caramel ganache, 1.7 oz (48g), the product is placed into a clear plastic box package and then put into a paper box package. The label declared "***Salted Caramel Bonbons *** Shell: 60% dark chocolate, 32%…
Category
Food
Distribution
2 states
HighFDA (Food)·F-1942-2017·2017-04-19
Dolcetta Peppermint Caramel Truffles Recalled for Undeclared Soy and Milk
Dolcetta Artisan Sweets is recalling Peppermint Caramel Truffles because the product contains undeclared soy lecithin and milk. The recall affects 100 boxes distributed in Oregon and Washington.
Product
Peppermint Caramel Truffles are dark chocolate truffle with peppermint and caramel, 3.9 oz (110g), individually wrapped in clear cellophane and then wrapped in a paper box. The label declared "***Peppermint Caramel Truffles***60% dark chocolate, 72% dark chocolate, cane…
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1784-2017·2017-04-19
Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.
Product
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1932-2017·2017-04-19
Dolcetta Artisan Sweets Recalls Dark Orange Bars Due to Undeclared Soy
Dolcetta Artisan Sweets is recalling 164 Dark Orange Bars distributed in Oregon and Washington because the product contains undeclared soy lecithin.
Product
Dark Orange Bar is dark chocolate with bits of candied orange zest, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1928-2017·2017-04-19
Dolcetta Artisan Sweets Recalls Dark Chocolate Peppermint Snowflakes for Undeclared Soy
Dolcetta Artisan Sweets is recalling 90 bags of Dark Chocolate Peppermint Snowflakes in Oregon and Washington due to undeclared soy lecithin.
Product
Dark Chocolate Peppermint Snowflakes are dark chocolate flavored with peppermint oil, 100g (3.5 oz), the product is wrapped in a plastic heat sealed bag.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1883-2017·2017-04-19
Vegetarian Minced Meat Recalled for Undeclared Wheat Allergen
Companion Foods Corp. is recalling Vegetarian Minced Meat with Shiitake because an FDA inspection found wheat was not properly declared in the ingredient list.
Product
VEGETARIAN MINCED MEAT WITH SHIITAKE 5 1/3 oz.. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10932 6 Companion Foods Corp. Taipei, Taiwan
Category
Food
Distribution
3 states