The Recall Desk

Manufacturer

Hospira, Inc.

257 recalls in our database name Hospira, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
257
Critical
18
Severe
104
Most recent
2017-05-31

Of the 257 recalls from Hospira, Inc. we have scored against our rubric, 18 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 104 (40%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 257

  • HighFDA (Devices)·Z-1624-2014·2014-05-28

    Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

    Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2014·2014-05-28

    Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect

    Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.

    Product
    LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1623-2014·2014-05-28

    Hospira Recalls Latex-Free Extension Sets Due to Packaging Seal Defect

    Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2014·2014-05-28

    Hospira Recalls Cystoscopy Sets Due to Potential Sterile Package Seal Defect

    Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2014·2014-05-07

    Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues

    Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.

    Product
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1482-2014·2014-05-07

    Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies

    Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.

    Product
    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2014·2014-05-07

    Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

    Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

    Product
    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1261-2014·2014-04-30

    Hospira Recalls Potassium Chloride Vials Due to Particulate Matter

    Hospira is recalling 255,900 vials of Potassium Chloride for Injection due to the presence of red and black particulate matter identified as iron oxide.

    Product
    Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2014·2014-04-30

    Hospira Recalls HemoSet IV Sets Due to Incorrect Lower Lid Component

    Hospira is recalling 3,893 HemoSet IV sets because an incorrect lower lid was used during manufacturing, which changes the drop rate from 15 to 10 drops per mL.

    Product
    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
    Category
    Medical Device
    Distribution
    14 states
  • CriticalFDA (Drugs)·D-1234-2014·2014-04-23

    Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

    Hospira, Inc. is recalling 1% Lidocaine Hydrochloride Injection vials because oxidized stainless steel was found in the product.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1226-2014·2014-04-16

    Hospira Recalls Demerol Ampoules Due to Missing Container Labels

    Hospira Inc. is recalling 237,850 ampoules of Demerol (meperidine HCL) because the immediate container labels are missing. The recall is nationwide.

    Product
    Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1161-2014·2014-03-26

    Hospira Recalls Marcaine Injection Vials Due to Metal Particulate Matter

    Hospira is recalling 40,360 vials of Marcaine (bupivacaine hydrochloride) injection because some units contain visible metal particles that discolor the solution.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1096-2014·2014-03-12

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising sterility.

    Product
    0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1147-2014·2014-03-12

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 115,500 vials of Bupivacaine Hydrochloride injection due to a confirmed report of visible particulate matter embedded in the glass vials.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1126-2014·2014-03-12

    Hospira Recalls LifeShield Blood Sets Due to Assembly Errors

    Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.

    Product
    *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2014·2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1035-2014·2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2014·2014-01-29

    Hospira Recalls Propofol Vials Due to Glass Particulate Matter

    Hospira is recalling 126,425 vials of Propofol Injectable Emulsion due to a glass defect that could release particulate matter into the solution.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-461-2014·2014-01-22

    Hospira Recalls Aminosyn II Amino Acid Injection Due to Particulate Matter

    Hospira is recalling 17,256 containers of Aminosyn II 10% Amino Acid Injection because a human hair was found in the injection port.

    Product
    Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-395-2014·2014-01-08

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns

    Hospira Inc. is recalling 65,109 vials of Bupivacaine Hydrochloride with Epinephrine due to a potential breach in the aseptic process caused by equipment failure.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-380-2014·2013-12-25

    Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter

    Hospira Inc. is recalling 118,100 vials of 0.25% Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-381-2014·2013-12-25

    Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter

    Hospira Inc. is recalling 119,600 vials of Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2014·2013-12-18

    Hospira Recalls Receptal Canisters Due to Suction Failure

    Hospira is recalling 1L Receptal Canisters because the canister and liner may not seat properly, preventing the creation of necessary suction.

    Product
    Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-023-2014·2013-12-11

    Hospira Recalls Morphine Sulfate Injection Due to Vial Leakage

    Hospira is recalling 29,700 vials of Morphine Sulfate Injection because a confirmed report indicated vial neck breakage caused leakage, compromising sterility.

    Product
    Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hospira

American pharmaceutical company

Country
United States
Founded
2004
Parent company
Pfizer

Official website

Source: Wikidata (Q1470525), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.