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.

42726–42750 of 50511

HighFDA (Devices)·Z-2262-2013·2013-10-02
Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects
Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1952-2013·2013-10-02
Snoqualmie Falls Candy Factory Recalls Coconut Peanut Brittle for Milk Allergen
Snoqualmie Falls Candy Factory is recalling Coconut Peanut Brittle because the label lists butter and cream but omits milk, a major allergen.
Product
Coconut Peanut Brittle's label is read in parts:"***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free…
Category
Food
Distribution
1 state
HighFDA (Food)·F-1945-2013·2013-10-02
James Farm Cut Green Beans Recalled for Listeria Contamination
Restaurant Depot is recalling James Farm brand cut green beans due to Listeria monocytogenes contamination found in private laboratory testing.
Product
JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and…
Category
Food
Distribution
8 states
HighFDA (Food)·F-1950-2013·2013-10-02
Snoqualmie Falls Candy Factory Recalls Pecan Brittle for Milk Allergen Mislabeling
Snoqualmie Falls Candy Factory is recalling Pecan Brittle because the label declares butter or cream but fails to list milk as an ingredient.
Product
Pecan Brittle's label is read in parts: "***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2271-2013·2013-10-02
Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk
Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.
Product
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The…
Category
Medical Device
Distribution
51 states
HighFDA (Food)·F-1944-2013·2013-10-02
American Nut Company Recalls Mixed Nuts for Undeclared Wheat Allergen
American Nut Company is recalling specific 25-pound mixed nut products because they may contain undeclared wheat, a major food allergen.
Product
Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs)
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2264-2013·2013-10-02
Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1958-2013·2013-10-02
Taylor Farms Salad Kit Recalled for Undeclared Milk Allergen
Taylor Farms is recalling Sensations Asian Supreme Salad Kits because they contain feta cheese with undeclared milk, a FALCPA violation.
Product
Sensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2275-2013·2013-10-02
Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button
Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.
Product
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2013·2013-10-02
BD Recalls Epilor Syringes Due to Plunger Sticking Hazard
Becton Dickinson is recalling BD Epilor syringes because the plunger may stick, preventing users from detecting loss of resistance during epidural procedures.
Product
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2282-2013·2013-10-02
Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use
Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke during use.
Product
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion…
Category
Medical Device
Distribution
5 states
HighFDA (Food)·F-1947-2013·2013-10-02
Semifreddi's Almond Biscotti Recalled for Undeclared Milk and Soy Allergens
Semifreddi's Inc. is recalling Almond Biscotti products due to undeclared milk and soy allergens. Consumers should check their 'Enjoy By' dates and stop consuming the product.
Product
Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with "Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12…
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2263-2013·2013-10-02
Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect
Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.
Product
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2013·2013-10-02
Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System
Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.
Product
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-2265-2013·2013-10-02
Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw
Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1913-2013·2013-10-02
Breaded Frozen Shrimp Recalled for Undeclared Shellfish and Wheat Allergens
Gourmet Express Marketing is recalling breaded frozen shrimp because the packaging failed to declare shellfish and wheat allergens.
Product
Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2013·2013-10-02
Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error
Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1948-2013·2013-10-02
Semifreddi's Chocolate Dipped Almond Biscotti Recalled for Undeclared Allergens
Semifreddi's Inc. is recalling Chocolate Dipped Almond Biscotti due to undeclared milk and soy allergens in ingredients.
Product
Chocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with "Enjoy By" dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product Size and UPC codes: 0.65 oz., case of 100 units 758843915943 0.89 oz., tub of 22 units 758843916001 1.3…
Category
Food
Distribution
8 states
HighNHTSA·13V481000·2013-09-30
Spartan School Bus Chassis Recall for Loose Steering Wheel Nut
Spartan Motors is recalling 2011-2014 school bus chassis because an insufficiently tightened steering wheel nut may cause loss of vehicle control.
Product
SPARTAN — SPARTAN SB
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13E053000·2013-09-30
Emmett Door Recalls RV Doors With Fastec Locks Due to Jamming Risk
Emmett Door is recalling 4,231 RV doors equipped with Fastec locks where the key can jam the deadbolt, potentially trapping occupants inside the vehicle.
Product
LATCHES/LOCKS/LINKAGES recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V478000·2013-09-30
ATC Trailers Recalled for Door Lock Defect That May Jam Deadbolt
Aluminum Trailer Company is recalling 2008-2013 Quest, RSX, and Raven trailers because a door lock defect may jam the deadbolt, trapping occupants inside.
Product
ATC — ATC RSX, QUEST, RAVEN
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13293·2013-09-30
Festool Recalls TS 55 REQ Plunge Cut Circular Saws Due to Laceration Hazard
Festool is recalling about 5,200 TS 55 REQ plunge cut circular saws in the U.S. because the plunge lock can engage unexpectedly, leaving the blade exposed and posing a laceration risk.
Product
TS 55 REQ Plunge Cut Circular Saw
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·13V477000·2013-09-30
Charmac Recalls 2006-2007 Trailers Due to Door Lock Jamming Risk
Charmac Trailers is recalling 2006-2007 Horse, Cargo, and Sports Trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.
Product
CHARMAC — CHARMAC HORSE TRAILER, CARGO TRAILER, SPORTS TRAILER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V473000·2013-09-27
Stealth Cargo Trailer Recall for Door Lock Jamming Hazard
Stealth Enterprises is recalling 2009-2014 cargo trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.
Product
STEALTH — STEALTH STEEL BLACKHAWK, ALUMINUM BLACKHAWK, ALUMINUM PREDATOR, ALUMINUM MOUNTAINEER
Category
Vehicle
Distribution
Distributed nationwide