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.

11501–11525 of 29163

SevereFDA (Drugs)·D-1750-2019·2019-08-21
Infusion Options Recalls Avastin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Avastin infusion products because of a lack of assurance of sterility. The recall is limited to New York.
Product
AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1812-2019·2019-08-21
Infusion Options Recalls IV Fluids Due to Sterility Concerns
Infusion Options, Inc. is recalling specific IV fluid products in New York due to a lack of assurance of sterility.
Product
Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1782-2019·2019-08-21
Infusion Options Recalls Granisetron Infusion Due to Sterility Concerns
Infusion Options, Inc. is recalling Granisetron 1000 mcg/50 mL NS infusion products in New York due to a lack of assurance of sterility.
Product
GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1791-2019·2019-08-21
Infusion Options Recalls Methylprednisolone Due to Sterility Concerns
Infusion Options, Inc. is recalling Methylprednisolone 10 mg/0.16 mL IVP products due to a lack of assurance of sterility. The recall is limited to New York.
Product
METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2065-2019·2019-08-21
Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software
Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.
Product
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1747-2019·2019-08-21
Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific trastuzumab and emtansine infusion products in New York due to a lack of assurance of sterility.
Product
ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2262-2019·2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1818-2019·2019-08-21
Infusion Options Recalls Vincristine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific vincristine infusion products in New York due to a lack of assurance of sterility.
Product
VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1775-2019·2019-08-21
Infusion Options Recalls Eribulin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific Eribulin infusion products in New York due to a lack of assurance of sterility.
Product
ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBULIN 1.89 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1773-2019·2019-08-21
Entyvio Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.
Product
ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1819-2019·2019-08-21
Ferric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was distributed in New York.
Product
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1801-2019·2019-08-21
Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV products in New York due to a lack of assurance of sterility.
Product
PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1770-2019·2019-08-21
Infusion Options Recalls Doxorubicin Syringes Due to Sterility Concerns
Infusion Options, Inc. is recalling various Doxorubicin IV syringes in New York due to a lack of assurance of sterility.
Product
Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE; Doxorubicin 75 MG / 37.5 ML IVP SYRINGE; Doxorubicin 125 MG / 62.5 ML SYRINGE IVP; Doxorubicin 93 MG / 46.5 ML IV SYRINGE; Doxorubicin 112 MG / 56 ML IVP SYRINGE; Doxorubicin 50 MG / 25 ML IVP…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1807-2019·2019-08-21
Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific Ramucirumab infusion products in New York due to a lack of assurance of sterility.
Product
RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1771-2019·2019-08-21
Infusion Options Recalls Doxorubicin Liposomal Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions in New York due to a lack of assurance of sterility.
Product
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2265-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2266-2019·2019-08-21
Medline Silicone Drain Recalled for Risk of Breaking During Use
Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1799-2019·2019-08-21
Infusion Options Recalls Paclitaxel Albumin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Paclitaxel Albumin infusions in New York due to a lack of assurance of sterility.
Product
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB PACLITAXEL ALBUMIN 165 mg / 100 ml NS IVPB; PACLITAXEL ALBUMIN 150 mg /100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1798-2019·2019-08-21
Infusion Options Recalls Paclitaxel Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Paclitaxel infusion bags in New York due to a lack of assurance of sterility.
Product
PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1809-2019·2019-08-21
Infusion Options Recalls Rituxan Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Rituxan infusion bags in New York due to a lack of assurance of sterility.
Product
RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2267-2019·2019-08-21
Smith & Nephew Wound Drain Recall Due to Breakage Risk
Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.
Product
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1803-2019·2019-08-21
Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Pemetrexed infusion products in New York due to a lack of assurance of sterility.
Product
PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1749-2019·2019-08-21
Atezolizumab Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Atezolizumab 1200 mg/250 mL in New York due to a lack of assurance of sterility.
Product
ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1777-2019·2019-08-21
Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Fluorouracil infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Product
Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; Fluorouracil 3920 MG QS 92 ML 0.9% NACL; Fluorouracil 3760 mg QS 100 ml NS CASS; Fluorouracil 4000 MG QS 92 ml 0.9% NACL; Fluorouracil 3140 MG QS 240 ML NS PUMP; Fluorouracil 2400 MG QS 96 ML 0.9% NACL…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1785-2019·2019-08-21
Infliximab Infusion Bags Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Infliximab 300 mg/250 mL infusion bags due to a lack of assurance of sterility. The recall affects New York.
Product
InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state