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.

11126–11150 of 29159

SevereFDA (Drugs)·D-0094-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Injections Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.
Product
Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2592-2019·2019-10-09
Medtronic Recalls 10 Units of Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2692-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters for Structural Defect
Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0113-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
Product
Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0022-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2588-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 12 units of the SHERPA NX ACTIVE GUIDING CATHETER because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0088-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
Product
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0027-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0019-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns
Colonia Care Pharmacy is recalling 6 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The affected product was distributed via patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0086-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.
Product
PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0121-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2631-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 531 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0028-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed.
Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0093-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 258 vials of Sermorelin Acetate and GHRP-2 because the product lacks assurance of sterility.
Product
Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2737-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 29 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0114-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
Product
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0075-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,290 syringes of Moxifloxacin 0.1% ophthalmic injection nationwide due to a lack of assurance of sterility.
Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2748-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2733-2019·2019-10-09
Medtronic Recalls Six Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0014-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Hydroxyprogesterone Caproate Injections for Sterility Concerns
Colonia Care Pharmacy is recalling 18 vials of C-Hydroxyprogesterone Caproate 250mg/mL injections because the sterility of the product cannot be guaranteed.
Product
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2695-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2648-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 136 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2703-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 12 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070", REF SA6SAR10. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2611-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2663-2019·2019-10-09
Medtronic Recalls 18 Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 18 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. for cardiovascular use
Category
Medical Device
Distribution
0 states