Browse Device Recalls

61 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 61 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 61 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 28, 2025	SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2	Certain pumps have potentially been released from service with defective grease applied to the ca...	Class II	Baxter Healthcare Corporation
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Feb 5, 2025	Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX	There is the potential for missing motor mounting screws, which may have occurred during the serv...	Class I	Baxter Healthcare Corporation
Nov 19, 2024	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro...	Devices were identified as released after repair without full testing being performed, which incl...	Class II	Baxter Healthcare Corporation
Nov 19, 2024	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr...	Devices were identified as released after repair without full testing being performed, which incl...	Class II	Baxter Healthcare Corporation
Jul 17, 2024	Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi...	The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele...	Class II	Baxter Healthcare Corporation
Jun 14, 2024	Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2	Improperly performed testing prior to release	Class II	Baxter Healthcare Corporation
Apr 17, 2024	Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S ...	Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ...	Class II	YAMAHA MOTOR CORPORATION
Jun 15, 2023	SIGMA Spectrum Infusion Pump, Product Code 35700BAX2	A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ...	Class I	Baxter Healthcare Corporation
Jun 15, 2023	The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35...	A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ...	Class I	Baxter Healthcare Corporation
Dec 29, 2021	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro...	There is the potential for reduced or non-delivery of medication, in some cases without alerting ...	Class I	Baxter Healthcare Corporation
Feb 22, 2021	The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc...	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ...	Class II	DePuy Orthopaedics, Inc.
Jan 8, 2021	Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri...	The taper dimensions may be out of specification due to a production issue during the manufacturi...	Class II	DePuy Orthopaedics, Inc.
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Nov 23, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr...	There is a potential software error during programming.	Class II	Baxter Healthcare Corporation
Sep 8, 2020	AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM...	The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ...	Class II	ESAOTE S.P.A
Sep 8, 2020	AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM...	The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ...	Class II	ESAOTE S.P.A
Jun 30, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)	Baxter is updating the device IFU for safety communication regarding cleaning practices.	Class I	Baxter Healthcare Corporation
Jun 30, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)	Baxter is updating the device IFU for safety communication regarding cleaning practices.	Class I	Baxter Healthcare Corporation
Jun 30, 2020	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)	Baxter is updating the device IFU for safety communication regarding cleaning practices.	Class I	Baxter Healthcare Corporation
Jul 18, 2018	P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830	This unit may be missing the screw/collet Assembly	Class II	DePuy Orthopaedics, Inc.
Jun 21, 2018	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), pro...	The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pum...	Class II	Baxter Healthcare Corporation
May 8, 2018	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf...	The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t...	Class II	Baxter Healthcare Corporation
May 8, 2018	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf...	The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Apr 3, 2018	Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570...	Service technician improperly documented final release testing on product, indicating that the fu...	Class II	Baxter Healthcare Corporation
Dec 21, 2017	(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100,...	The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system ...	Class II	DePuy Orthopaedics, Inc.
Oct 6, 2017	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI...	Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu...	Class II	Baxter Healthcare Corporation
Jan 26, 2017	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product...	SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha...	Class II	Baxter Healthcare Corporation
Sep 28, 2016	Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to...	Class II	Baxter Healthcare Corp.
Sep 28, 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to...	Class II	Baxter Healthcare Corp.
Sep 28, 2016	V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca...	Class II	Baxter Healthcare Corp.
Jan 8, 2016	SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an optio...	Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. Thi...	Class II	DePuy Orthopaedics, Inc.
Sep 8, 2015	Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The S...	DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Int...	Class II	DePuy Orthopaedics, Inc.
Mar 2, 2015	Master Drug Library Software version 8.0, Product Code 35723V080, to be used ...	Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump d...	Class II	Baxter Healthcare Corp
Sep 3, 2014	SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled...	One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps acc...	Class II	Baxter Healthcare Corp.
Feb 7, 2014	SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U...	Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum...	Class I	Baxter Healthcare Corp.
Jan 14, 2014	The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Ma...	Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013...	Class II	Instrumentarium Dental, PaloDEx Group Oy
Dec 9, 2013	PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) U...	Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presen...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel P...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B....	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. K...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. K...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, 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.