Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

15276–15300 of 29202

SevereFDA (Drugs)·D-0060-2018·2017-11-08
SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0042-2018·2017-11-08
Pacific Coast Fruit Recalls Bagged Salads for Listeria Risk
Pacific Coast Fruit Company is voluntarily recalling multiple types of bagged processed salads due to potential Listeria monocytogenes contamination.
Product
Small Veg Tray w/Dressing, 10 oz., RETAIL item # 71675, Pacific Coast Fruit brand, UPC 20728 01713. Ingredients: Broccoli, Cauliflower, Cherry Tomato, Carrots and Litehouse Ranch Dressing.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-0044-2018·2017-11-08
Pacific Coast Fruit Recalls Veggie Mix Bags Due to Listeria Risk
Pacific Coast Fruit Company is voluntarily recalling specific Veggie Mix Bags due to potential Listeria monocytogenes contamination.
Product
Veggie Mix Bag, 4/20 oz., RETAIL item # 72013, Pacific Coast Fruit, UPC 20728 01710 Ingredients: Cauliflower, Broccoli and mini peel baby carrots
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0059-2018·2017-11-08
SCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0063-2018·2017-11-08
SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine CADD Cassettes
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine CADD cassettes due to a lack of assurance of sterility.
Product
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0156-2018·2017-11-08
Triple B Corporation Recalls Asparagus Salad Kit Due to Listeria Risk
Triple B Corporation is recalling Asparagus Salad Kits due to possible Listeria monocytogenes contamination from broccoli supplied by Mann Packing.
Product
Asparagus Salad Kit, Produced by CP Fresh of Seattle, WA, 1 x 5 lb. per case, UPC 45009 85722 4. The ingredients are: ASPARAGUS, NAPPA CABBAGE, RED PEPPERS, CARROTS, RED ONIONS, BROCCOLI, SNAP PEAS.
Category
Food
Distribution
5 states
SevereUSDA FSIS·118-2017·2017-11-08
Nestle Recalls Pork and Beef Hot Pockets for Undeclared Allergens
Nestle Prepared Foods is recalling approximately 26,400 pounds of frozen pork and beef products because they contain undeclared eggs, milk, soy, and wheat.
Product
Nestle Prepared Foods Company Recalls Pork and Beef Products Due To Misbranding and Undeclared Allergens
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0164-2018·2017-11-08
Triple B Veggie Medley Recalled for Listeria Contamination Risk
Triple B Corporation is recalling Veggie Medley products due to possible Listeria monocytogenes contamination from recalled broccoli.
Product
Veggie Medley, Alaska Carrot, 12 x 16 oz. per case, UPC 45009 00332 4 The ingredients are: Baby carrot peeled, cauliflower cello, broccoli florette.
Category
Food
Distribution
5 states
SevereFDA (Drugs)·D-0061-2018·2017-11-08
SCA Pharmaceuticals Recalls Hydromorphone and Bupivacaine Injection Bags
SCA Pharmaceuticals is recalling 60 bags of Hydromorphone and Bupivacaine injection due to a lack of assurance of sterility.
Product
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0069-2018·2017-11-08
Greencore Recalls Ham Sandwiches for Listeria Contamination Risk
Greencore USA, LLC is recalling specific ham sandwiches due to potential Listeria monocytogenes contamination. Consumers in seven Northeastern states should check their pantries.
Product
(1)Turkey Hill Fresh Selects Ham salad on Homestyle Bread, 4.9 oz (2)American Food and Vending Enza Choice Ham Salad on White Bread, 4.7 oz Packaged in plastic wedge container.
Category
Food
Distribution
7 states
SevereFDA (Food)·F-0161-2018·2017-11-08
Triple B Broccoli Crunch Kit Recalled for Listeria Contamination
Triple B Corporation is recalling Broccoli Crunch Kit due to possible Listeria monocytogenes contamination. The product was distributed in five western states.
Product
Broccoli Crunch Kit, Alaska Carrot brand, 1 x 6 lb. per case, UPC 97327 10070 6 The ingredients are: Raisin seedless, sunflower seed kernel, broccoli crown w/ice, red onion, broccoli florette, bacon bits, coleslaw
Category
Food
Distribution
5 states
SevereFDA (Drugs)·D-0066-2018·2017-11-08
SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,221 syringes of Phenylephrine HCl 100 mcg/mL due to a lack of assurance of sterility.
Product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0047-2018·2017-11-08
Pacific Coast Fruit Company Recalls Cauliflower Cakes for Listeria Risk
Pacific Coast Fruit Company is voluntarily recalling Kit Roasting Cauli Cakes due to potential Listeria monocytogenes contamination from a supplier.
Product
Kit Roasting Cauli Cakes, 8.10 lbs, Food Service item # 72894, UPC 20728 72894. Ingredients: Cauliflower, Breadcrumbs, paremsan cheese, italian Parsley, Garlic, Mayo pouch, Oil Blend, Salt and Pepper.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0058-2018·2017-11-08
A1 Slim Dietary Supplement Recalled for Undeclared Unapproved Drug Ingredients
Kiriko, LLC. is recalling A1 Slim dietary supplements because FDA analysis found undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine.
Product
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] Bar-Code A105212014
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0064-2018·2017-11-08
SCA Pharmaceuticals Recalls Morphine Sulfate Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection due to a lack of assurance of sterility.
Product
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0056-2018·2017-11-08
Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters
Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Product
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Category
Medical Device
Distribution
0 states
SevereFDA (Food)·F-0072-2018·2017-11-08
Hannaford Ham Salad Club Rolls Recalled for Listeria Risk
Greencore USA is recalling Hannaford Ham Salad Club Rolls due to potential Listeria monocytogenes contamination. The product was sold in several northeastern states.
Product
Hannaford Ham Salad Club Roll, 5.1 oz
Category
Food
Distribution
7 states
SevereFDA (Drugs)·D-0062-2018·2017-11-08
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Bags
SCA Pharmaceuticals is recalling 116 bags of fentanyl and bupivacaine injection due to a lack of assurance of sterility.
Product
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0160-2018·2017-11-08
Triple B Corporation Recalls Stir Fry Products Due to Listeria Risk
Triple B Corporation is recalling specific stir fry vegetable mixes due to possible Listeria monocytogenes contamination from recalled broccoli.
Product
Stir Fry (GL) 4 x 10 oz. per case, UPC 45009 85367 7. Stir Fry Mix - BULK, 1 x 5 lb. per case, UPC 45009 85374 5. Mix Stir Fry Veg-LG, 6 x 20 oz. per case, UPC 45009 85517 6. These products are produced by CP Fresh of Seattle, WA. The ingredients are: GREEN PEPPERS…
Category
Food
Distribution
5 states
SevereNHTSA·17V702000·2017-11-06
Crysteel Recalls 2017 Dump Bodies for Driveshaft Detachment Risk
Crysteel is recalling 2017 dump bodies built on Isuzu NRR-Series chassis because the driveshafts may detach from the rear universal joint, potentially causing loss of propulsion and increasing crash risk.
Product
CRYSTEEL — CRYSTEEL DUMP BODY
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V696000·2017-11-03
Jayco Recalls 2016-2018 Jay Flight SLX Trailers Due to Fire Risk
Jayco is recalling 2016-2018 Jay Flight SLX trailers because the battery circuit lacks overcurrent protection, increasing fire risk during electrical shorts.
Product
JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V698000·2017-11-03
Phoenix Motorcars Recalls Zeus 300 and 305 Vans for Tire Failure Risk
Phoenix Motorcars is recalling 2015-2017 Zeus 300 and 305 shuttle vans because rear tires may fail when fully loaded, increasing crash risk.
Product
PHOENIX — PHOENIX ZEUS 305, ZEUS 300
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V697000·2017-11-03
Highland Ridge Recalls 2018 Light Trailers Due to Underrated Safety Chains
Highland Ridge RV is recalling 2018 Light recreational trailers because the safety chains are rated for a lower weight than the trailer's actual capacity, increasing crash risk if detached.
Product
HIGHLAND RIDGE FW — HIGHLAND RIDGE FW LIGHT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V694000·2017-11-02
Van-Con Recalls Dual Rear Wheel School Buses Due to Seat Barrier Defect
Van-Con is recalling 2007-2017 Dual Rear Wheel school buses because the seat barrier behind the driver may be pinned, preventing it from deforming in a crash.
Product
VAN-CON — VAN-CON DUAL REAR WHEEL
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·117-2017·2017-11-02
CC Kitchens Recalls Meat and Poultry Products Produced Without Inspection
CC Kitchens LLC is recalling approximately 269 pounds of ready-to-eat meat and poultry products produced without federal inspection in Ohio.
Product
CC Kitchens LLC Recalls Meat and Poultry Products Produced Without Benefit of Inspection
Category
Food
Distribution
1 state