Browse Device Recalls

352 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 352 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 352 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 17, 2017	Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th...	The syringe plunger grippers may fail to automatically close around the syringe plunger press whe...	Class II	CareFusion 303, Inc.
Nov 6, 2017	Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used...	Reports of incorrect priming volume due to manufacturing with incorrect tubing.	Class II	CareFusion 303, Inc.
Aug 9, 2017	Alaris Pump Module model 8100 manufactured between November 2011 and March 20...	The recalling firm has received reports of increased or decreased flows that have occurred in cer...	Class II	CareFusion 303, Inc.
Jul 18, 2017	AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ...	Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect...	Class II	Vyaire Medical
Jun 30, 2017	VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used...	Punctures in blister packaging that was detected during the packaging process.	Class II	CareFusion 303, Inc.
Jun 12, 2017	Alaris PC Unit, Model 8015	BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios whi...	Class II	CareFusion 303, Inc.
Jun 12, 2017	Alaris Pump Module model 8100	There is a potential risk that could cause unintended flow in the older, centered sear door latch...	Class II	CareFusion 303, Inc.
Feb 23, 2017	Manometer, 550 ml three-Way Stopcock; STERILE;	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 23, 2017	JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.)...	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 23, 2017	ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 23, 2017	JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d....	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 23, 2017	Thoracentesis/ Paracentesis Kit 10/CS; STERILE;	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 23, 2017	JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G ...	The integrity of the sterile packaging is potentially compromised.	Class II	Carefusion 2200 Inc
Feb 20, 2017	MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGu...	CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0....	Class II	CareFusion 303, Inc.
Feb 20, 2017	MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. M...	CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter beca...	Class II	CareFusion 303, Inc.
Dec 2, 2016	Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/...	During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.	Class I	CareFusion 303, Inc.
Nov 17, 2016	SmartSite Add-On Bag Access Device, Model No. 10013365	CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leaka...	Class II	CareFusion 303, Inc.
Nov 1, 2016	Alaris System PC unit, model no. 8000 and 8015. The central programming, mon...	Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef...	Class II	CareFusion 303, Inc.
Aug 8, 2016	Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syr...	A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to ...	Class II	CareFusion 303, Inc.
Jul 1, 2016	DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ...	BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou...	Class I	Carefusion 2200 Inc
Jun 29, 2016	Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored...	The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag...	Class II	Carefusion 2200 Inc
Jun 29, 2016	Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ...	The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag...	Class II	Carefusion 2200 Inc
Jun 27, 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam...	Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi...	Class II	Cardinal Health
May 17, 2016	AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	TCA Board, 16542A A continuous ventilator intended to mechanically control o...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 17, 2016	Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan...	CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect...	Class I	Carefusion 211 Inc dba Carefusion
May 12, 2016	Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr...	A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea...	Class II	CareFusion 303, Inc.
Mar 24, 2016	Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, ...	The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the s...	Class II	CareFusion 303, Inc.
Feb 15, 2016	Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007	CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages a...	Class II	CareFusion 303, Inc.
Feb 12, 2016	Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092	CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca...	Class II	CareFusion 303, Inc.
Jan 15, 2016	Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product...	Customers reported issues when scanning medications with the scanners. When a user scans a medic...	Class II	CareFusion 303, Inc.
Nov 12, 2015	Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end...	CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during...	Class II	CareFusion 303, Inc.
Nov 5, 2015	Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administe...	CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection a...	Class II	CareFusion 303, Inc.
Oct 9, 2015	SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic...	CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.	Class II	CareFusion 303, Inc.
Jul 21, 2015	Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect...	Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring...	Class I	CareFusion 303, Inc.
May 13, 2015	Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us...	An issue with the cancel functionality used during atypical infusion programming to cancel user i...	Class II	CareFusion 303, Inc.
Apr 3, 2015	CareFusion AVEA ventilator, all models. Product Usage: A continuous venti...	A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occl...	Class I	Carefusion 211 Inc dba Carefusion
Mar 13, 2015	CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra...	Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3...	Class II	Vital Signs Colorado Inc.
Mar 13, 2015	Introduction Pack. A device inserted into an endotracheal tube to aid in the...	Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3...	Class II	Vital Signs Colorado Inc.
Mar 12, 2015	Alaris PC units, Model No. 8015. Infusion pump.	CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur up...	Class II	CareFusion 303, Inc.
Jan 13, 2015	SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio...	CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i...	Class II	CareFusion 303, Inc.

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.