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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,963medical device recall records

2,598FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1212

29,963 detailed records are currently available in this category.

Medical DeviceFeb 25, 2015

Terumo HX2 Temperature Management System provides temperature control of two independent recall — FDA Z-1116-2015

Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE…

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation

Medical DeviceFeb 25, 2015

Intuitive Surgical HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000 recall — FDA Z-1118-2015

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceFeb 25, 2015

Biomet Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component recall — FDA Z-1122-2015

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the…

Class IIFDA: TerminatedBiomet, Inc.

Medical DeviceFeb 25, 2015

Teleflex R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is recall — FDA Z-1124-2015

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff…

Class IIFDA: TerminatedTeleflex, Inc.

Medical DeviceFeb 25, 2015

GE Healthcare This correction applies to all GE Healthcare MRI systems with superconducting recall — FDA Z-1035-2015

At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in…

Class IFDA: TerminatedGE Healthcare

Medical DeviceFeb 25, 2015

Haemonetics TEG Hemostasis System Level II Control recall — FDA Z-1130-2015

Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

Class IIFDA: TerminatedHaemonetics Corporation

Medical DeviceFeb 25, 2015

Siemens Medical Solutions USA Artis One; The Artis One is an angiography system developed recall — FDA Z-1119-2015

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceFeb 25, 2015

Pulsion Medical Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) recall — FDA Z-1121-2015

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Class IIFDA: TerminatedPulsion Medical Inc.

Medical DeviceFeb 25, 2015

Biomet Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component recall — FDA Z-1123-2015

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the…

Class IIFDA: TerminatedBiomet, Inc.

Medical DeviceFeb 25, 2015

Nidek MC-500 Multicolor Laser Photocoagulator recall — FDA Z-1127-2015

The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Class IIFDA: TerminatedNidek Inc.

Medical DeviceFeb 25, 2015

Cincinnati Sub-Zero Products Cold Therapy Pad - cold water circulating pad, one unit per recall — FDA Z-1129-2015

Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

Class IIFDA: TerminatedCincinnati Sub-Zero Products Inc.

Medical DeviceFeb 25, 2015

Alivecor SFO Alive ECG App 2.1.2 recall — FDA Z-1125-2015

Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.

Class IIIFDA: TerminatedAlivecor SFO

Medical DeviceFeb 25, 2015

Mako Surgical Restoris Partial Knee Application (PKA) RIO (TGS 2.0) recall — FDA Z-1128-2015

When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger)…

Class IIFDA: TerminatedMako Surgical Corporation

Medical DeviceFeb 25, 2015

CME BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA recall — FDA Z-1126-2015

CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

Class IIFDA: TerminatedCME America, LLC

Medical DeviceFeb 25, 2015

Intuitive Surgical HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200 recall — FDA Z-1117-2015

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceFeb 18, 2015

Teleflex MAQUET Servo Humidifier 163 recall — FDA Z-1008-2015

Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be…

Class IFDA: TerminatedTeleflex, Inc.

Medical DeviceFeb 18, 2015

Elekta Precise Digital Accelerator Intended to be used for radiation therapy treatments of recall — FDA Z-1088-2015

Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceFeb 18, 2015

Synthes Hemostatic Bone Putty, for use as a water-soluble implant material and for use in recall — FDA Z-1094-2015

Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.

Class IIFDA: TerminatedSynthes, Inc.

Medical DeviceFeb 18, 2015

Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Intra-Aortic Balloon Pump and recall — FDA Z-1062-2015

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap…

Class IIFDA: TerminatedMaquet Datascope Corp - Cardiac Assist Division

Medical DeviceFeb 18, 2015

Teleflex Medical LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use recall — FDA Z-1085-2015

The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Natus Medical EPWorks software used in the Protektor 32 Product Usage: Uses recall — FDA Z-1067-2015

Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have…

Class IIFDA: TerminatedNatus Medical Inc.

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL recall — FDA Z-1109-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL recall — FDA Z-1108-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx recall — FDA Z-1078-2015

Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

Class IIFDA: TerminatedTeleflex Medical

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.