Recall Register

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GETINGE US SALES LLC

FDA recalling firm · 9 enforcement events · 12 product records · 2017–2019 · NJ

GETINGE US SALES LLC has 9 FDA enforcement events on this register (12 product records) between 2017 and 2019: 9 device; the busiest year was 2019 with 6.

0% of its events are Class I; the most common class is Class II (8). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
13 Nov 2019Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000DeviceClass II1Ongoing
22 Aug 2019The 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 operative preclotting step, including…DeviceClass II1Terminated
22 Jul 2019Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.DeviceClass II1Terminated
5 Jun 2019PulsioFlex 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 Monitor presents the derived parameters…DeviceClass II1Terminated
20 Mar 2019Maquet 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 diaphragmatic electrical activity, (Edi signals) by…DeviceClass III1Terminated
8 Jan 2019Maquet 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.DeviceClass II4Terminated
7 Feb 2018VOLISTA 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 surgical lights may be installed in surgical…DeviceClass II1Terminated
3 Jan 2018HEMASHIELD Knitted Double Velour Cardiovascular FabricDeviceClass II1Terminated
16 Nov 2017ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094DeviceClass II1Terminated

By type and class

Device9
Class II8
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for GETINGE US SALES LLC by year initiated.

Questions and answers

How many FDA recalls has GETINGE US SALES LLC had?

9 enforcement events (12 product records) on this register, 2017–2019: 9 device.

Are any GETINGE US SALES LLC recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are GETINGE US SALES LLC recalls?

8 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.