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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 1194

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

Medical DeviceMay 20, 2015

Biomerieux Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton recall — FDA Z-1601-2015

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

Class IIFDA: TerminatedBiomerieux Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 3/16 in. Double Trocar with Wound Drain Curved Trocar recall — FDA Z-1563-2015

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 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock recall — FDA Z-1595-2015

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

ICU Medical 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating recall — FDA Z-1589-2015

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 1/8 in. Double Trocar with Wound Drain Curved Trocar recall — FDA Z-1565-2015

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

Brainlab AG ExacTrac 6.x. is software used to place patients at an accurately defined point recall — FDA Z-1582-2015

ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.

Class IIFDA: TerminatedBrainlab AG

Medical DeviceMay 13, 2015

ICU Medical 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon recall — FDA Z-1591-2015

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

BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE recall — FDA Z-1586-2015

The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.

Class IIFDA: TerminatedBard Peripheral Vascular Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 3/16 in. Round Drain with Trocar Curved Trocar with recall — FDA Z-1568-2015

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

Stryker Instruments Div. of Stryker 3/16 in. Trocar with Single Drain Curved Trocar with recall — FDA Z-1562-2015

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

Stryker Instruments Div. of Stryker 1/4 in. Trocar with Single Drain Curved Trocar with recall — FDA Z-1566-2015

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

Spacelabs Healthcare Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA recall — FDA Z-1577-2015

Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2…

Class IIFDA: TerminatedSpacelabs Healthcare Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker Universal Charger Product Usage: The Stryker Universal recall — FDA Z-1587-2015

The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.

Class IIIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceMay 13, 2015

Eos Imaging EOS, Digital radiography system used in general radiographic examinations recall — FDA Z-1460-2015

When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with…

Class IIFDA: TerminatedEos Imaging Inc.

Medical DeviceMay 13, 2015

B. Braun Medical CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn recall — FDA Z-1576-2015

There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A…

Class IIFDA: TerminatedB. Braun Medical, Inc.

Medical DeviceMay 13, 2015

ICU Medical 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore recall — FDA Z-1590-2015

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

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MHI-TM2000 Linear Accelerator System recall — FDA Z-1574-2015

The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the…

Class IIFDA: TerminatedMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY…

Medical DeviceMay 13, 2015

Philips Ultrasound EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ recall — FDA Z-1579-2015

When Epiq 7 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

Stryker Instruments Div. of Stryker 1/4 in. Curved Trocar with Wound Drain Curved Trocar recall — FDA Z-1572-2015

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 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon recall — FDA Z-1593-2015

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

Siemens Medical Solutions USA AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a recall — FDA Z-1583-2015

If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMay 13, 2015

ICU Medical 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon recall — FDA Z-1592-2015

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

Fujifilm Medical Systems U.S.A Aspire HD, Full Field Digital, System, x-Ray, Mammographic recall — FDA Z-1585-2015

User Manual lacks a description for handling some errors even though the system can be recovered from such errors

Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.

Medical DeviceMay 13, 2015

Stryker Instruments Div. of Stryker 1/8 in. Trocar with Single Drain Curved Trocar with recall — FDA Z-1564-2015

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

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.