Getinge Us Sales Llc

Complete recall history across all FDA and CPSC categories — 12 total recalls

Getinge Us Sales Llc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by Getinge Us Sales Llc

Date Product Reason Class
Nov 13, 2019 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane... Sterile barrier system may be compromised Class II
Aug 22, 2019 The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ... Based on an internal incident report, Getinge/Intervascular SAS has identifie... Class II
Jul 22, 2019 Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Reversed expiration and manufacturing date on the label Class II
Jun 5, 2019 PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.... The monitor displays an error message . The error message states "internal e... Class II
Mar 20, 2019 Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes Class III
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Num... The affected flat screen monitor holders might not be compliant with groundin... Class II
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuratio... The affected flat screen monitor holders might not be compliant with groundin... Class II
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Par... The affected flat screen monitor holders might not be compliant with groundin... Class II
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD... The affected flat screen monitor holders might not be compliant with groundin... Class II
Feb 7, 2018 VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AI... The manufacturer received complaints indicating that the device's central han... Class II
Jan 3, 2018 HEMASHIELD Knitted Double Velour Cardiovascular Fabric A probable mislabeling of the product: a different-sized product is reference... Class II
Nov 16, 2017 ALM XTEN Surgical Light intended to provide visible illumination for the surg... Getinge has received complaints concerning the X TEN Surgical Lights whose sp... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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