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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.

30,447medical device recall records

2,766FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1214

30,447 detailed records are currently available in this category.

Medical DeviceFeb 18, 2015

Arrow International ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit recall — FDA Z-1082-2015

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier recall — FDA Z-1098-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Medical Components, Inc dba MedComp Hemodialysis Catheters and PICCs: Product recall — FDA Z-1083-2015

Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of…

Class IIFDA: TerminatedMedical Components, Inc dba MedComp

Medical DeviceFeb 18, 2015

Teleflex Medical Hudson RCI Humidifier Adaptor, 040 contained in the following units recall — FDA Z-1095-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN recall — FDA Z-1105-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN recall — FDA Z-1100-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier recall — FDA Z-1099-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Stryker Instruments Div. of Stryker Flyte Togas are components of the Stryker Flyte System recall — FDA Z-1077-2015

A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have…

Class IIIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceFeb 18, 2015

Teleflex Medical MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg recall — FDA Z-1051-2015

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Class IFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 640 SW, 650ML W/040 ADAPTOR recall — FDA Z-1103-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Teleflex Medical AQUAPAK 340 SW, 340 ML W/404 ADAPTOR recall — FDA Z-1097-2015

The packages may contain foreign material (black particles).

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceFeb 18, 2015

Biomet Spine Telluride Percutaneous Rod Inserter Long, Model #7706-1904 recall — FDA Z-1089-2015

The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during…

Class IIFDA: TerminatedBiomet Spine, LLC

Medical DeviceFeb 18, 2015

Stryker Craniomaxillofacial Division MEDPOR TITAN MAX Orbital Floor and Wall (OFW) recall — FDA Z-1093-2015

Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment.…

Class IIFDA: TerminatedStryker Craniomaxillofacial Division

Medical DeviceFeb 18, 2015

Integra LifeSciences The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per recall — FDA Z-1084-2015

Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

Class IIFDA: TerminatedIntegra LifeSciences Corporation

Medical DeviceFeb 18, 2015

Siemens Medical Solutions USA The Siemens Symbia S series is intended to aid in detecting recall — FDA Z-1086-2015

There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceFeb 18, 2015

Siemens Medical Solutions USA The Siemens Symbia T series is intended to aid in detecting recall — FDA Z-1087-2015

There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceFeb 18, 2015

Virtual Imaging Digital Mobile X-ray Systems used to take diagnostic radiographic exposures recall — FDA Z-1064-2015

There is a potential for unintended and erratic motion.

Class IIFDA: TerminatedVirtual Imaging, Inc.

Medical DeviceFeb 11, 2015

Covidien Puritan Bennett 980 Ventilator System, Model No recall — FDA Z-1058-2015

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

Class IIFDA: TerminatedCovidien LP (formerly Nellcor Puritan Bennett Inc.)

Medical DeviceFeb 11, 2015

Becton Dickinson & Company BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not recall — FDA Z-1055-2015

The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

Class IIFDA: TerminatedBecton Dickinson & Company

Medical DeviceFeb 11, 2015

Medtronic Sofamor Danek USA KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size recall — FDA Z-1057-2015

The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.

Class IIFDA: TerminatedMedtronic Sofamor Danek USA Inc.

Medical DeviceFeb 11, 2015

Covidien Trellis-8 Peripheral Infusion System recall — FDA Z-1018-2015

A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon…

Class IFDA: TerminatedCovidien

Medical DeviceFeb 11, 2015

Zimmer Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots recall — FDA Z-1052-2015

Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To…

Class IIFDA: TerminatedZimmer, Inc.

Medical DeviceFeb 11, 2015

The Anspach Effort 16cm Minimally Invasive Attachment recall — FDA Z-1037-2015

Customer complaint indicating the color bands on the MIA16-G1 were not correct.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceFeb 11, 2015

Siemens Medical Solutions USA ACUSON SC2000 Ultrasound System, Model 10433816, component recall — FDA Z-1056-2015

The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

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.