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.

11051–11075 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-2704-2019·2019-10-09
Medtronic Sherpa NX Active Guiding Catheter Recall for Material Loss
Medtronic Vascular is recalling 11 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 JCL3.5, .070", REF SA6JCL35. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0097-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0092-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Product
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0104-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.
Product
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2664-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 406 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0007-2020·2019-10-09
Colonia Care Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.
Product
C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0065-2020·2019-10-09
KRS Global Biotechnology Recalls Ketamine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2020·2019-10-09
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/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0029-2020·2019-10-09
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. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/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-2582-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 14 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, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0106-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Bl
Category
Drug
Distribution
Distributed nationwide
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-0076-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Moxifloxacin 0.1% ophthalmic injection syringes due to a lack of assurance of sterility. The recall covers 9,920 syringes distributed nationwide.
Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2734-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 330 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2586-2019·2019-10-09
Medtronic Recalls Two Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling two 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, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2723-2019·2019-10-09
Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling six 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 SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2684-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 163 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 ALR1-2, .070", REF SA6ALR12. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2742-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 33 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2668-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 488 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2599-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 20 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, NOTO, 100CM, 070", REF SA6NOTO. 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 (Devices)·Z-2707-2019·2019-10-09
Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling 26 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 MAC4.0, .070", REF SA6MAC40. 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 (Devices)·Z-2656-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 69 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 EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
Category
Medical Device
Distribution
0 states