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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 12 FDA device recalls.

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DateProductReasonClassFirm
Nov 13, 2019 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane... Sterile barrier system may be compromised Class II GETINGE US SALES LLC
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 identified that the one (1) H... Class II GETINGE US SALES LLC
Jul 22, 2019 Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Reversed expiration and manufacturing date on the label Class II GETINGE US SALES LLC
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 error restart or serv... Class II GETINGE US SALES LLC
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 GETINGE US SALES LLC
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 grounding requirements. As a... Class II GETINGE US SALES LLC
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 grounding requirements. As a... Class II GETINGE US SALES LLC
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 grounding requirements. As a... Class II GETINGE US SALES LLC
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 grounding requirements. As a... Class II GETINGE US SALES LLC
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 handle holder detaches ... Class II GETINGE US SALES LLC
Jan 3, 2018 HEMASHIELD Knitted Double Velour Cardiovascular Fabric A probable mislabeling of the product: a different-sized product is referenced on the product pac... Class II GETINGE US SALES LLC
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 spring arms have broke... Class II GETINGE US SALES LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.