The Recall Desk

Manufacturer

GETINGE US SALES LLC

12 recalls in our database name GETINGE US SALES LLC as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
4
Most recent
2019-12-18

Of the 12 recalls from GETINGE US SALES LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (33%) 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.

1–12 of 12

  • HighFDA (Devices)·Z-0677-2020·2019-12-18

    Getinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns

    Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.

    Product
    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2019·2019-10-02

    Getinge Recalls One Vascular Graft Due to Incorrect Packaging Label

    Getinge is recalling one HEMASHIELD GOLD vascular graft that was incorrectly packed in a carton labeled for a HEMASHIELD PLATINUM graft.

    Product
    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the op
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2433-2019·2019-09-11

    Getinge CO2 Absorber Recalled for Reversed Expiration and Manufacturing Dates

    Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.

    Product
    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2019·2019-07-31

    Getinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages

    Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.

    Product
    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1221-2019·2019-05-01

    Maquet Edi Catheter Recalled for Incorrect Expiry Date Labeling

    Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.

    Product
    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0989-2019·2019-03-13

    Maquet Flat Screen Monitor Holder Recalled for Grounding Non-Compliance

    Getinge US Sales LLC is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.

    Product
    Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0990-2019·2019-03-13

    Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect

    Getinge is recalling four Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.

    Product
    Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0987-2019·2019-03-13

    Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect

    Getinge is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.

    Product
    Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0988-2019·2019-03-13

    Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect

    Getinge is recalling six Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.

    Product
    Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1349-2018·2018-04-18

    Getinge Recalls VOLISTA StandOP Surgical Lights Due to Handle Detachment Risk

    Getinge is recalling 5,214 VOLISTA StandOP surgical lights because the central handle holder can detach, potentially dropping particles into the sterile field during procedures.

    Product
    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1172-2018·2018-04-04

    Getinge Hemashield Cardiovascular Fabric Recalled for Packaging Mislabeling

    Getinge US Sales LLC is recalling Hemashield Knitted Double Velour Cardiovascular Fabric because the packaging label lists a different product size than the actual item inside.

    Product
    HEMASHIELD Knitted Double Velour Cardiovascular Fabric
    Category
    Medical Device
    Distribution
    1 state