Hospira Recalls
257 recalls on record · June 20, 2012 to May 31, 2017 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 8, 2013Medical DevicesFDA
Hospira Inc. recalls The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospita
Hazard: Pump shutting off during use without warning.
May 8, 2013Medical DevicesFDA
Hospira Inc. recalls GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device d
Hazard: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
May 8, 2013Medical DevicesFDA
Hospira Inc. recalls GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device
Hazard: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
May 8, 2013DrugsFDA
Hospira Inc. recalls Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, ND
Hazard: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
May 8, 2013DrugsFDA
Hospira Inc. recalls Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST,
Hazard: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
May 1, 2013DrugsFDA
Hospira Inc. recalls Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., L
Hazard: Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
April 24, 2013Medical DevicesFDA
Hospira Inc. recalls The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospita
Hazard: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
April 24, 2013Medical DevicesFDA
Hospira Inc. recalls The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospita
Hazard: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
April 24, 2013DrugsFDA
Hospira Inc. recalls Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 6
Hazard: Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
April 24, 2013DrugsFDA
Hospira Inc. recalls Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60
Hazard: Non-Sterility: Confirmed customer complaint of product contaminated with mold.
April 10, 2013DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Ho
Hazard: Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
April 3, 2013DrugsFDA
Hospira Inc. recalls Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg
Hazard: Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
April 3, 2013DrugsFDA
Hospira, Inc. recalls Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-
Hazard: CGMP Deviations: Shipment of product not approved for release.
March 27, 2013DrugsFDA
Hospira Inc. recalls METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-
Hazard: Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
March 13, 2013DrugsFDA
Hospira Inc. recalls HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC.
Hazard: Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
March 13, 2013DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Hazard: Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
March 6, 2013DrugsFDA
Hospira Inc. recalls 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, ND
Hazard: Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
March 6, 2013DrugsFDA
Hospira, Inc. recalls Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102
Hazard: Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
February 20, 2013DrugsFDA
Hospira Inc. recalls Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4
Hazard: Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
February 13, 2013DrugsFDA
Hospira Inc. recalls Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, N
Hazard: Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
February 13, 2013DrugsFDA
Hospira Inc. recalls Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, H
Hazard: Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
January 9, 2013Medical DevicesFDA
Hospira Inc. recalls Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage:
Hazard: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
January 9, 2013Medical DevicesFDA
Hospira Inc. recalls Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following co
Hazard: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
January 9, 2013Medical DevicesFDA
Hospira Inc. recalls Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following con
Hazard: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
January 9, 2013DrugsFDA
Hospira Inc. recalls Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Hazard: Presence of Particulates; may contain glass particles
December 26, 2012DrugsFDA
Hospira, Inc. recalls Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx o
Hazard: Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
December 26, 2012DrugsFDA
Hospira, Inc. recalls Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC
Hazard: Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
December 19, 2012Medical DevicesFDA
Hospira Inc. recalls Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that prov
Hazard: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
December 19, 2012Medical DevicesFDA
Hospira Inc. recalls Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral modul
Hazard: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
December 19, 2012Medical DevicesFDA
Hospira Inc. recalls Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area net
Hazard: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.