The Recall Desk

Manufacturer

Fenwal Inc

10 recalls in our database name Fenwal Inc as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
2
Most recent
2023-03-22

Of the 10 recalls from Fenwal Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (20%) are Severe.

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.

1–10 of 10

  • HighFDA (Devices)·Z-1254-2023·2023-03-22

    Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs

    Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.

    Product
    Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2023·2023-03-22

    Medical Device Apheresis Kit Recalled Due to Stress Leak Risk

    Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.

    Product
    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1343-2021·2021-04-14

    Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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. Vigi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2019·2019-08-21

    Fenwal Volumat MC Agilia Infusion Pump Software Recall

    Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.

    Product
    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2019·2019-05-01

    Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk

    Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.

    Product
    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Par
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2019·2019-04-03

    Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use

    Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.

    Product
    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1523-2013·2013-06-19

    Fenwal Recalls AMICUS Exchange Kits Due to Labeling Error

    Fenwal is voluntarily recalling 114 AMICUS Exchange Kits because the product was cleared for European use only but distributed in the US.

    Product
    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
    Category
    Medical Device
    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.

FENWAL

Source: Wikidata (Q127693025), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.