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.

19551–19575 of 32115

SevereFDA (Drugs)·D-1406-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 220 cassettes of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate.
Product
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereUSDA FSIS·066-2016·2016-07-27
Tim Hortons Chicken Noodle Soup Mix Recalled for Import Inspection Failure
The TDL Group Corp. is recalling approximately 636 pounds of Tim Hortons Chicken Noodle Soup Mix because the products were imported from Canada without receiving required FSIS re-inspection.
Product
The TDL Group Corp. Recalls Dried Chicken Soup Mix Products Distributed Without Benefit of Import Inspection
Category
Food
Distribution
4 states
SevereFDA (Drugs)·D-1388-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services, LLC is recalling 230 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1422-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 655 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1765-2016·2016-07-27
Garden Fresh Foods Recalls Sunflower Kernels in Salad Kits
Garden Fresh Foods is recalling sunflower kernels in salad kits due to potential Listeria contamination. No illnesses have been reported.
Product
Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods Cool Breeze Health SALD Kit #2052, Net WT 7.06 lbs, 3.20 kg. 0 01 11596 72052 1.
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1691-2016·2016-07-27
Whole Foods Market Recalls White Kimchi for Undeclared Allergens
Whole Foods Market is recalling 4-pound packages of White Kimchi sold in Los Angeles due to undeclared fish, shellfish, and/or tree nuts.
Product
White Kimchi
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1378-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 65 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1416-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services is recalling 5,727 sterile injectable cassettes containing fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.
Product
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1369-2016·2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 140 bags of compounded sufentanil and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1742-2016·2016-07-27
Rucker's Sweet N Salty Sunflower Kernels Recalled for Listeria Contamination
Rucker's Wholesale & Service Co. is recalling 504 bags of Sweet N Salty sunflower kernels due to Listeria monocytogenes contamination.
Product
SWEET N SALTY 7.5 OZ.packaged in a clear plastic bag with white sticky label. The product is under UPC code 052545003398 and includes the brand names Big R Store's, Coastal, and Fin feather Fur Outfitter's.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1382-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
PharMEDium Services is recalling 740 syringes of compounded fentanyl and bupivacaine because glass particulate was found in the active ingredient.
Product
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1431-2016·2016-07-27
FDA Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services is recalling 5 syringes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1420-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 936 cassettes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the sterile injectable solution.
Product
4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V560000·2016-07-27
Jayco Recalls Travel Trailers Due to Brake Control Defect
Jayco is recalling 2016-2017 travel trailers equipped with Sway Command systems because the trailer brakes may fail to function after a sway event.
Product
JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO FIFTH WHEEL JAY FEATHER, OCTANE, EAGLE, JAY FLIGHT
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1383-2016·2016-07-27
Pharmedium Recalls Hydrocodone and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 55 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1425-206·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate Matter
PharMEDium Services is recalling 2,713 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1403-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine HCl sterile injectable drugs due to the presence of glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1402-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 95 bags of compounded fentanyl and bupivacaine injectable solutions nationwide because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1405-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 2,006 bags of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1366-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 315 cassettes of 0.15% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1762-2016·2016-07-27
Wellsley Farms Organic Mixed Vegetables Recalled for Listeria Risk
CRF Frozen Foods is recalling Wellsley Farms Organic Mixed Vegetables due to potential Listeria monocytogenes contamination. Consumers should check Best By dates and discard or return the product.
Product
Frozen Organic Mixed Vegetables, Wellsley Farms Organic brand, net wt. 4 lb. The UPC is 8 88670 01013 6. Product label bears cooking instructions and listed as: MICROWAVE 1. Pour one quarter contents of bag into a microwave safe dish with 1/4 cup water. 2. Cook covered…
Category
Food
Distribution
35 states
SevereFDA (Devices)·Z-2096-2016·2016-07-27
Stryker Recalls Angiographic Catheters Due to Tip Breakage
Stryker is recalling 167 AngioDynamics Soft Vu Omni Flush Angiographic Catheters because the tips broke off before use.
Product
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Category
Medical Device
Distribution
11 states
SevereFDA (Drugs)·D-1423-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 3,474 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate.
Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1741-2016·2016-07-27
Rucker's Recalls Cajun Hot Mix Due to Listeria Contamination
Rucker's Wholesale & Service Co. is recalling 4,671 bags of Cajun hot mix because the sunflower kernels are contaminated with Listeria monocytogenes.
Product
Cajun hot mix 6 OZ Family Choice Brand, packaged in a clear plastic bag with brown and blue sticky labile. UPC 052545012680
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1413-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 700 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
Category
Drug
Distribution
Distributed nationwide