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FDA public records

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.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1066

28,992 detailed records are currently available in this category.

Medical DeviceJun 22, 2016

Zimmer Gmbh Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder recall — FDA Z-2003-2016

In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted…

Class IIFDA: TerminatedZimmer Gmbh

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV recall — FDA Z-1987-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Beckman Coulter Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an recall — FDA Z-1956-2016

Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceJun 22, 2016

Siemens Medical Solutions USA BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product recall — FDA Z-1997-2016

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.

Medical DeviceJun 22, 2016

Siemens Medical Solutions USA BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product recall — FDA Z-2000-2016

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

Class IIFDA: TerminatedSiemens Medical Solutions USA Inc.

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology recall — FDA Z-1974-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela PICC with PASV Valve Technology recall — FDA Z-1975-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve recall — FDA Z-1980-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve recall — FDA Z-1982-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Zimmer Trabecular Metal Technology TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H recall — FDA Z-1951-2016

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are…

Class IIFDA: TerminatedZimmer Trabecular Metal Technology, Inc.

Medical DeviceJun 22, 2016

Carefusion 211 Inc dba Carefusion AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A recall — FDA Z-1889-2016

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may…

Class IFDA: TerminatedCarefusion 211 Inc dba Carefusion

Medical DeviceJun 22, 2016

Leica Biosystems Richmond Ariol is an automated scanning microscope and image analysis recall — FDA Z-1948-2016

An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

Class IIIFDA: TerminatedLeica Biosystems Richmond Inc.

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve recall — FDA Z-1977-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV IR-145 Kit under the recall — FDA Z-1968-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Arthrex BioSync Anatomic Cotton Wedge, 20 x 5.5 mm recall — FDA Z-1962-2016

Potential for polystyrene particulate presence.

Class IIFDA: TerminatedArthrex, Inc.

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve recall — FDA Z-1978-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV recall — FDA Z-1988-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Carefusion 211 Inc dba Carefusion AVEA GDE/UIM upgrade kit, 12283-PMN A continuous recall — FDA Z-1898-2016

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may…

Class IFDA: TerminatedCarefusion 211 Inc dba Carefusion

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company Xcela Hybrid PICC with PASV Valve recall — FDA Z-1979-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company BioFlo Hybrid PICC with ENDEXO and PASV recall — FDA Z-1986-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

Carefusion 211 Inc dba Carefusion Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A recall — FDA Z-1895-2016

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may…

Class IFDA: TerminatedCarefusion 211 Inc dba Carefusion

Medical DeviceJun 22, 2016

Zimmer Trabecular Metal Technology REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER recall — FDA Z-1954-2016

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are…

Class IIFDA: TerminatedZimmer Trabecular Metal Technology, Inc.

Medical DeviceJun 22, 2016

Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve recall — FDA Z-1983-2016

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the…

Class IIFDA: TerminatedNavilyst Medical, Inc., an AngioDyamics Company

Medical DeviceJun 22, 2016

CarboFix Orthopedics Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide recall — FDA Z-1991-2016

Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Class IIFDA: TerminatedCarboFix Orthopedics, Ltd.

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.