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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Nov 28, 2023 External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 28, 2023 EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd... Class II Natus Medical Incorporated
Nov 18, 2022 The Natus Cranial Access Kit is designed to be a complete, single use and dis... Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra... Class II Natus Medical Incorporated
May 22, 2017 The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for ... Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulat... Class II Natus Medical Incorporated
Apr 3, 2017 Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 200... The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so... Class II Natus Medical Incorporated
Oct 28, 2016 Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to... neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recal... Class II Natus Medical Incorporated
Sep 16, 2016 Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides photothe... The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE b... Class II Natus Medical Incorporated
Aug 25, 2016 The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item n... NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the... Class II Natus Medical Incorporated
Apr 22, 2016 Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filte... The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. ... Class II Natus Medical Incorporated
Apr 11, 2016 Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assemb... The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Photother... Class II Natus Medical Incorporated
Jan 8, 2016 Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the res... Class II Natus Medical Incorporated
Nov 11, 2015 Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.... During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Q... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Aug 5, 2015 Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part ... The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show ... Class II Natus Medical Incorporated
Mar 16, 2015 Natus neoBLUE blanket LED Phototherapy system which includes the following it... neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some... Class II Natus Medical Incorporated
Jan 2, 2015 EPWorks software used in the Xltek Protektor Stimulator Product Usage: In... Software error occurs when using remote monitoring; if the remote user tries to stop the free run... Class II Natus Medical Incorporated
Jan 2, 2015 EPWorks software used in the Protektor 32 Product Usage: Uses electroence... Software error occurs when using remote monitoring; if the remote user tries to stop the free run... Class II Natus Medical Incorporated
Nov 19, 2014 Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLU... Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 20... Class II Natus Medical Incorporated
May 21, 2012 Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure... Class II Natus Medical Incorporated
May 9, 2012 The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... Class I Natus Medical Incorporated

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.