Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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Date	Product	Reason	Class	Firm
Nov 5, 2014	EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1....	When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a...	Class II	Philips Ultrasound, Inc.
Nov 5, 2014	Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ...	Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ...	Class II	Toshiba American Medical Systems Inc
Nov 5, 2014	Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligen...	Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 5, 2014	Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr ...	An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior seale...	Class II	Custom Healthcare Systems, Inc.
Nov 5, 2014	Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coatin...	Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for ...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 5, 2014	Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ ...	Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di...	Class II	Gambro Renal Products Inc
Nov 5, 2014	Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revacle...	Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di...	Class II	Gambro Renal Products Inc
Nov 5, 2014	EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1....	When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a...	Class II	Philips Ultrasound, Inc.
Nov 5, 2014	Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10...	When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a...	Class II	Philips Ultrasound, Inc.
Nov 4, 2014	STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ...	Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i...	Class II	Advanced Sterilization Products
Nov 4, 2014	STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA...	Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i...	Class II	Advanced Sterilization Products
Nov 4, 2014	Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba...	A software anomaly was identified where the system may automatically transition from "Standby" to...	Class II	Bausch & Lomb Inc
Nov 4, 2014	Non-sterile drape	Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.	Class III	Novadaq Technologies, Inc.
Nov 4, 2014	LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QT...	The stem taper on this device is undersized; the gauge point is not deep enough.	Class II	Smith & Nephew, Inc.
Nov 4, 2014	LUNA Chest, Model No. LU4006	Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.	Class III	Novadaq Technologies, Inc.
Nov 4, 2014	STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA...	Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i...	Class II	Advanced Sterilization Products
Nov 4, 2014	LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QT...	The stem taper on this device is undersized; the gauge point is not deep enough.	Class II	Smith & Nephew, Inc.
Nov 4, 2014	STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ...	Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i...	Class II	Advanced Sterilization Products
Nov 4, 2014	Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor...	Internal testing and investigation of the packaging revealed cracks and holes in primary packaging	Class II	Pulsion Medical Inc
Nov 4, 2014	STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S...	Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i...	Class II	Advanced Sterilization Products
Nov 4, 2014	LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, Q...	The stem taper on this device is undersized; the gauge point is not deep enough.	Class II	Smith & Nephew, Inc.
Nov 4, 2014	McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items...	The blade retaining clip may be difficult to engage and thereby increase the possibility of a bl...	Class II	Aircraft Medical Limited
Nov 4, 2014	Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar...	A software anomaly was identified where the system may automatically transition from "Standby" to...	Class II	Bausch & Lomb Inc
Nov 4, 2014	Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa...	A software anomaly was identified where the system may automatically transition from "Standby" to...	Class II	Bausch & Lomb Inc
Nov 4, 2014	BrightView product code: 882478 BrightView X product code: 882480 BrightVie...	Software issues	Class II	Philips Medical Systems (Cleveland) Inc
Nov 4, 2014	Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Si...	Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T...	Class II	Medtronic MiniMed Inc.
Nov 3, 2014	8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate cont...		Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate con...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate contr...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuit...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Int...	Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control ...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control ...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer:...	Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they wer...	Class II	Bard Access Systems
Nov 3, 2014	8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, ceme...	Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotati...	Class II	Zimmer CAS
Nov 3, 2014	8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of I...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control o...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intu...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intu...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate contro...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuit...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitiv...	Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of ...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	MOSAIQ Product Usage: MOSAIQ is an oncology information system used to ma...	A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose ro...	Class II	Elekta, Inc.
Nov 3, 2014	8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, Inc.
Nov 3, 2014	8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of I...	Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur...	Class II	Intuitive Surgical, 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.