PlainRecalls

Getinge US Sales LLC

Compiled from official public sources by the editorial team.

12 recalls on record · Latest: Dec 18, 2019

Getinge US Sales LLC Recall Insight

Getinge US Sales LLC appears on 12 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.012% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 18, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 12 entries, severity tagging shows 0 critical, 11 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 12 of 12 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (12). The date window on this page runs from Apr 4, 2018 to Dec 18, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

FDA Devices Moderate Oct 2, 2019

The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen.…

FDA Devices Moderate Sep 11, 2019

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

FDA Devices Moderate Jul 31, 2019

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients wh…

FDA Devices Low May 1, 2019

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 sing…

FDA Devices Moderate Mar 13, 2019

Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or …

FDA Devices Moderate Mar 13, 2019

Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to su…

FDA Devices Moderate Mar 13, 2019

Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed …

FDA Devices Moderate Mar 13, 2019

Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support…

FDA Devices Moderate May 30, 2018

ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD56780…

FDA Devices Moderate Apr 18, 2018

VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961…

FDA Devices Moderate Apr 4, 2018

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.