Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

7926–7950 of 29121

SevereFDA (Food)·F-0871-2021·2021-08-18
Dark Chocolate Malt Balls recalled for undeclared peanuts
DSD Merchandisers is recalling Dark Chocolate Malt Balls because some containers were filled with Dark Chocolate Peanut Butter malt balls instead, creating a risk for consumers with peanut allergies who may not be aware of the peanut content.
Product
Dark Chocolate Malt Balls in plastic container; 9 oz./ 255g UPC: 6 5143370179 0 Packed on the same equipment as products that contain milk, eggs, tree nuts, peanuts, wheat and soy. Distributed by DSD Merchandisers, Inc., Livermore, CA 64551
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2189-2021·2021-08-18
Heart Pump Device Recalled for Increased Mortality and Device Failure
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Product
HeartWare HVAD Pump Implant Kit, REF 1104
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0718-2021·2021-08-18
Compounded Progesterone Oil Recalled for Non-Sterility Risk
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
Product
C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0717-2021·2021-08-18
Hydromorphone HCL-Bupivacaine HCL Injectable Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5M
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0708-2021·2021-08-18
Injectable Drug Syringes Recalled for Non-Sterility
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0714-2021·2021-08-18
Injectable Drug Sufentanil-Bupivacaine-Baclofen Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Product
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-2165-2021·2021-08-18
Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0707-2021·2021-08-18
FDA Recalls Non-Sterile Fentanyl-Bupivacaine-Baclofen Injection
Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.
Product
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0709-2021·2021-08-18
Injectable drug recalled for non-sterility concerns in Texas and Puerto Rico
Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0706-2021·2021-08-18
Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Product
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-2204-2021·2021-08-18
Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Category
Medical Device
Distribution
9 states
SevereFDA (Drugs)·D-0712-2021·2021-08-18
Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility
Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.
Product
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-2110-2021·2021-08-18
Spectrum IQ Infusion System Recalled for Connectivity Errors
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
Product
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Category
Medical Device
Distribution
1 state
SevereNHTSA·21E076000·2021-08-18
Palfinger Knuckle Boom Cranes Recalled Due to Base Cracking Risk
Palfinger is recalling specific Knuckle Boom Cranes because the base may crack, potentially causing the crane to detach from the truck mount.
Product
EQUIPMENT:MECHANICAL:BOOM/CRANE/LADDER recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0713-2021·2021-08-18
Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.
Product
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereCPSC·21186·2021-08-18
Ravin White Arrow Nocks Recalled for Injury Risk
Ravin Crossbows is recalling white arrow nocks that can fail to engage properly with the bowstring, allowing the crossbow to discharge unexpectedly during re-nocking and causing finger injuries. About 220,000 units are affected.
Product
Ravin® white arrow nocks
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0705-2021·2021-08-18
Injectable drug recalled for non-sterility in Texas and Puerto Rico
Med Shop Total Care Inc. is recalling a Bupivacaine HCL-Lioresal PF injectable drug due to non-sterility concerns. The recall affects a 41 mL syringe product distributed in Texas and Puerto Rico.
Product
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0898-2021·2021-08-18
McCormick Perfect Pinch Italian Seasoning Recalled for Salmonella
McCormick & Company is recalling McCormick Perfect Pinch Italian Seasoning due to potential Salmonella contamination. Consumers should not consume the affected product.
Product
McCormick Perfect Pinch Italian Seasoning 1.31 oz. Plastic Bottles, 36 packages per case; 2.25 oz. Plastic bottles, 6 packages per case
Category
Food
Distribution
15 states
SevereFDA (Drugs)·D-0716-2021·2021-08-18
Injectable Drug Recalled for Non-Sterility Risk
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0900-2021·2021-08-18
Frank's Red Hot Buffalo Ranch Seasoning Recalled for Salmonella Contamination
McCormick & Company is recalling Frank's Red Hot Buffalo Ranch Seasoning due to potential Salmonella contamination. The product was distributed to multiple U.S. states and Canada.
Product
Frank s Red Hot Buffalo Ranch Seasoning 153g, Plastic Bottles, 36 packages per case
Category
Food
Distribution
15 states
SevereFDA (Drugs)·D-0711-2021·2021-08-18
Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl
Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
2 states
SevereNHTSA·21V635000·2021-08-12
Land Rover Recalls LR4 and Range Rover Sport for Fuel Leak Risk
Jaguar Land Rover is recalling 2010-2016 LR4 and 2010-2013 Range Rover Sport vehicles because a fuel tank flange may crack, causing a leak that increases fire risk.
Product
LAND ROVER — LAND ROVER LR4, RANGE ROVER SPORT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V633000·2021-08-12
GM Recalls 2013 Buick and Chevrolet Vehicles for Rear Suspension Defect
General Motors is recalling 2013 Buick Regal, Lacrosse, and Chevrolet Malibu vehicles because excessive corrosion protection on rear toe links may cause them to fracture, increasing crash risk.
Product
CHEVROLET — CHEVROLET, BUICK MALIBU, LACROSSE, REGAL
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V634000·2021-08-12
Utility Bodywerks Recalls Ram 4500 and 5500 Trucks for Brake Line Defect
Utility Bodywerks is recalling 2019-2020 Ram 4500 and 5500 trucks because improperly routed rear brake lines may chafe and leak, increasing crash risk.
Product
UTILITY BODYWERKS — UTILITY BODYWERKS RAM 4500, RAM 5500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21E074000·2021-08-12
Chrysler Recalls Mopar Side Air Bag Inflatable Curtains Due to Inflator Defect
Chrysler is recalling Mopar side air bag inflatable curtains sold as replacement parts because the inflator end cap may detach or the sidewall may rupture, posing an injury risk.
Product
AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
Category
Vehicle
Distribution
Distributed nationwide