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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 1195

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

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 1/8 in. Curved Trocar with Wound Drain Curved Trocar recall — FDA Z-1571-2015

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 13, 2015

Siemens Medical Solutions USA ACUSON SC2000 ultrasound systems at software versions VA20A or recall — FDA Z-1584-2015

In certain situations, loss of post exercise images can occur in Stress Echo.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker Ambulating Bulb Ambulating Bulb: The Ambulating Bulb recall — FDA Z-1573-2015

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 13, 2015

ICU Medical 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set recall — FDA Z-1588-2015

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 1/4 in. Double Trocar with Wound Drain Curved Trocar recall — FDA Z-1567-2015

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 13, 2015

Philips Ultrasound EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ recall — FDA Z-1578-2015

When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation…

Class IIFDA: TerminatedPhilips Ultrasound, Inc.

Medical DeviceMay 13, 2015

Zimmer NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be recall — FDA Z-1575-2015

The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This…

Class IIFDA: TerminatedZimmer, Inc.

Medical DeviceMay 13, 2015

ICU Medical 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon recall — FDA Z-1594-2015

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 3/16 in. Curved Trocar with Wound Drain Curved Trocar recall — FDA Z-1570-2015

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 13, 2015

Siemens Medical Solutions USA ACUSON SC2000 volume imaging ultrasound systems at software recall — FDA Z-1581-2015

In some cases, the system is unable to capture a clip or image during a routine scan.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 1/4 in. Round Drain with Trocar Curved Trocar with Wound recall — FDA Z-1569-2015

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 6, 2015

Fresenius Medical Care Holdings 2008 Series Hemodialysis Machines: 2008K with the following recall — FDA Z-1551-2015

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Class IIFDA: TerminatedFresenius Medical Care Holdings, Inc.

Medical DeviceMay 6, 2015

Fresenius Medical Care Holdings 2008 Series Hemodialysis Machines: 2008K2 with the following recall — FDA Z-1552-2015

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Class IIFDA: TerminatedFresenius Medical Care Holdings, Inc.

Medical DeviceMay 6, 2015

Spacelabs Healthcare Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo recall — FDA Z-1542-2015

Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds),…

Class IIFDA: TerminatedSpacelabs Healthcare Inc.

Medical DeviceMay 6, 2015

Vital Signs Colorado Introduction Pack. A device inserted into an endotracheal tube to aid recall — FDA Z-1557-2015

Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile…

Class IIFDA: TerminatedVital Signs Colorado Inc.

Medical DeviceMay 6, 2015

Steris AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation recall — FDA Z-1561-2015

STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time…

Class IIFDA: TerminatedSteris Corporation

Medical DeviceMay 6, 2015

Beckman Coulter MicroScan -Neg Breakpoint Combo Panel Type 34 recall — FDA Z-1522-2015

Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.

Class IIFDA: TerminatedBeckman Coulter, Inc.

Medical DeviceMay 6, 2015

Beckman Coulter MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels recall — FDA Z-1529-2015

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIFDA: TerminatedBeckman Coulter, Inc.

Medical DeviceMay 6, 2015

Alphatec Spine 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine recall — FDA Z-1547-2015

During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling…

Class IIFDA: TerminatedAlphatec Spine, Inc.

Medical DeviceMay 6, 2015

Beckman Coulter MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels recall — FDA Z-1530-2015

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIFDA: TerminatedBeckman Coulter, Inc.

Medical DeviceMay 6, 2015

Bard Access Systems PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The recall — FDA Z-1560-2015

Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion…

Class IIFDA: TerminatedBard Access Systems

Medical DeviceMay 6, 2015

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx recall — FDA Z-1407-2015

An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

Class IIFDA: TerminatedGE Healthcare

Medical DeviceMay 6, 2015

Therasage, LLC FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited recall — FDA Z-1540-2015

Product distributed without 510(k) approval

Class IIFDA: TerminatedTherasage, LLC.

Medical DeviceMay 6, 2015

Fresenius Medical Care Holdings 2008 Series Hemodialysis Machines: 2008T with the following recall — FDA Z-1550-2015

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Class IIFDA: TerminatedFresenius Medical Care Holdings, 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.