Browse Device Recalls

111 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 111 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 111 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 30, 2016	Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ...	Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,...	Class II	Hospira Inc., A Pfizer Company
Jul 28, 2016	Hospira MedNet Medication Management Suite software, version 6.1, List Number...	Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result...	Class II	Hospira Inc., A Pfizer Company
Jul 11, 2016	Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DEx...	B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tr...	Class II	B. Braun Medical, Inc.
Mar 25, 2016	The Plum 360 is a large volume infuser capable of delivering fluids for a var...	Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att...	Class II	Hospira Inc.
Mar 25, 2016	The Plum A+ is a dual-line volumetric infusion system designed to meet the gr...	Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att...	Class II	Hospira Inc.
Dec 22, 2015	The Symbiq infusion pump is a device used in a health care facility to pump f...	Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.	Class II	Hospira Inc.
Sep 22, 2015	Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi...	Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject...	Class II	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Jul 2, 2014	The Plum A+ Infusion System is designed to meet the fluid delivery requiremen...	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ...	Class I	Hospira Inc.
Jul 2, 2014	The Plum A+ Infusion System is designed to meet the fluid delivery requiremen...	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ...	Class I	Hospira Inc.
Jul 2, 2014	The Plum A+ Infusion System is designed to meet the fluid delivery requiremen...	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ...	Class I	Hospira Inc.
Jul 2, 2014	The Plum A+ Infusion System is designed to meet the fluid delivery requiremen...	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ...	Class I	Hospira Inc.
Jul 2, 2014	The Plum A+ Infusion System is designed to meet the fluid delivery requiremen...	One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ...	Class I	Hospira Inc.
Jun 11, 2014	Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Asse...	Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the p...	Class II	Hospira Inc.
Jun 6, 2014	The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ...	Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg...	Class II	Hospira Inc.
Mar 25, 2014	LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Consta...	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ...	Class II	Hospira Inc.
Mar 25, 2014	LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures...	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ...	Class II	Hospira Inc.
Mar 25, 2014	LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); Fo...	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ...	Class II	Hospira Inc.
Mar 25, 2014	LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compat...	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ...	Class II	Hospira Inc.
Mar 25, 2014	LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Rese...	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ...	Class II	Hospira Inc.
Feb 25, 2014	LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inc...	Hospira identified an incorrect lower lid (set component) had been supplied and was being used du...	Class II	Hospira Inc.
Feb 18, 2014	GemStar Docking Station, used with GemStar infusion pump, in combination with...	There are two situations that may occur when using the GemStar Docking Station, List Number 13075...	Class I	Hospira Inc.
Feb 3, 2014	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is...	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one...	Class I	Hospira Inc.
Feb 3, 2014	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is...	The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one...	Class I	Hospira Inc.
Jan 31, 2014	GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (...	The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump wi...	Class II	Hospira Inc.
Jan 24, 2014	LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi...	There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ...	Class II	Hospira Inc.
Jan 24, 2014	Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion...	There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ...	Class II	Hospira Inc.
Jan 24, 2014	Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d...	There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ...	Class II	Hospira Inc.
Oct 31, 2013	Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus...	Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly...	Class I	Hospira Inc.
Oct 31, 2013	Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl...	Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc...	Class I	Hospira Inc.
Oct 25, 2013	*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ...	Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb...	Class II	Hospira Inc.
Sep 10, 2013	Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, A...	Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta...	Class II	Hospira Inc.
Sep 10, 2013	Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Nu...	Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta...	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Sep 9, 2013	*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P...	Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.	Class II	Hospira Inc.
Aug 28, 2013	* 1) SYMBIQ One-Channel Infuser; * 2) SYMBIQ Two-Channel Infuser; **...	Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr...	Class II	Hospira Inc.
Jul 17, 2013	Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90...	Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System...	Class II	Hospira Inc.
Jun 18, 2013	LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE...	Hospira has received reports of customers experiencing air-in-line alarms related to administrati...	Class II	Hospira Inc.
Apr 1, 2013	List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Bloo...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 In...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP;...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, No...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE ...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Conver...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection S...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Apr 1, 2013	List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood...	It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t...	Class I	Hospira Inc.
Mar 21, 2013	The GemStar Pump is a small and lightweight, single channel infusion device d...	During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica...	Class II	Hospira 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.