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.

13976–14000 of 29188

SevereFDA (Drugs)·D-0960-2018·2018-07-25
Avella Recalls Norepinephrine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 2,280 bags of Norepinephrine Bitartrate in 5% Dextrose due to potential bag leakage and lack of sterility assurance.
Product
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0938-2018·2018-07-25
Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 1,500 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Product
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2445-2018·2018-07-25
NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk
NewDeal SA is recalling specific ADVANSYS MLP/DLP models because their use may cause superficial or deep infections requiring medical treatment.
Product
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
Category
Medical Device
Distribution
19 states
SevereFDA (Drugs)·D-0929-2018·2018-07-25
Avella Recalls CeFAZolin Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 2,500 bags of ceFAZolin 2 gm in NS 100mL due to potential bag leakage that compromises sterility.
Product
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2516-2018·2018-07-25
Medtronic Tri-Staple 2.0 Curved Tip Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0937-2018·2018-07-25
Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 1,860 bags of Midazolam 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Product
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2503-2018·2018-07-25
Endo GIA 45 mm Articulating Medium/Thick Reload Recalled for Missing Sled Component
COVIDIEN MEDTRONIC is recalling Endo GIA 45 mm Articulating Medium/Thick Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Product
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2510-2018·2018-07-25
Medtronic Endo GIA Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA 45 mm Extra Thick Black Articulating Reloads because a missing sled component may prevent staple formation, potentially leading to bleeding or leakage.
Product
Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0957-2018·2018-07-25
Avella Recalls Midazolam Syringes Due to Sterility Assurance Concerns
Avella of Deer Valley, Inc. is recalling 110 syringes of Midazolam 1 mg/mL due to a lack of assurance of sterility and potential bag leakage.
Product
Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0958-2018·2018-07-25
Avella Recalls NORepiNEPHrine 16 Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 520 bags of NORepiNEPHrine 16 injection due to potential bag leakage and lack of assurance of sterility.
Product
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0953-2018·2018-07-25
Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Product
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2497-2018·2018-07-25
RayStation Software Recalled for Potential Radiation Overdose Risk
RaySearch Laboratories is recalling RayStation treatment planning software versions 4.5 through 8A because a calculation error could lead to significant radiation overdosage during therapy.
Product
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0955-2018·2018-07-25
Avella Recalls Midazolam Syringes Due to Potential Sterility Issues
Avella of Deer Valley, Inc. is recalling specific lots of Midazolam 1 mg/mL syringes due to a lack of assurance of sterility and potential bag leakage.
Product
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2505-2018·2018-07-25
Medtronic Endo GIA Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0956-2018·2018-07-25
Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 220 bags of Midazolam 0.5mg/mL due to potential bag leakage and lack of assurance of sterility.
Product
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0935-2018·2018-07-25
Avella Recalls Hydromorphone Syringes Due to Sterility Assurance Concerns
Avella of Deer Valley, Inc. is recalling 275 single-dose hydromorphone syringes nationwide due to a lack of assurance of sterility caused by potential bag leakage.
Product
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2470-2018·2018-07-25
Ion Beam Applications Recalls Proteus 235 Nozzles Due to Crushing Risk
Ion Beam Applications is recalling 14 Proteus 235 nozzles because they may allow gantry rotation or proton irradiation when accessories are not correctly positioned, posing a risk of crushing or mistreatment.
Product
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0928-2018·2018-07-25
Avella Recalls Ropivacaine Pumps Due to Potential Sterility Compromise
Avella of Deer Valley is recalling 40 Ropivacaine OnQ pumps due to potential bag leakage that compromises sterility.
Product
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0950-2018·2018-07-25
Avella Recalls Hydromorphone Injection Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 660 bags of Hydromorphone injection due to potential leakage that compromises sterility.
Product
HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0931-2018·2018-07-25
Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley is recalling 420 bags of Epinephrine 4 mg in 5% Dextrose due to potential leakage that compromises sterility.
Product
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0951-2018·2018-07-25
Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential leakage and lack of sterility assurance.
Product
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2444-2018·2018-07-25
NewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk
NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.
Product
ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
Category
Medical Device
Distribution
19 states
SevereFDA (Drugs)·D-0963-2018·2018-07-25
Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Avella of Deer Valley is recalling 10,500 ephedrine sulfate syringes nationwide due to potential bag leakage and lack of sterility assurance.
Product
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0932-2018·2018-07-25
Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 700 bags of Epinephrine (USP) 4 mg due to potential leakage that compromises sterility.
Product
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0941-2018·2018-07-25
Avella Recalls Vancomycin Bags Due to Potential Leakage
Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises sterility.
Product
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
Category
Drug
Distribution
Distributed nationwide