Medical DeviceJun 22, 2016
Arthrex BioSync Anatomic Cotton Wedge, 16 x 6.5 mm recall — FDA Z-1960-2016
Potential for polystyrene particulate presence.
Class IIFDA: TerminatedArthrex, Inc.
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1065
28,992 detailed records are currently available in this category.
Medical DeviceJun 22, 2016
Arthrex BioSync Anatomic Cotton Wedge, 16 x 5.5 mm recall — FDA Z-1959-2016
Potential for polystyrene particulate presence.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceJun 22, 2016
Physio-Control LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed recall — FDA Z-1993-2016
The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially…
Class IIFDA: TerminatedPhysio-Control, Inc.
Medical DeviceJun 22, 2016
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066 recall — FDA Z-2001-2016
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
Class IIFDA: TerminatedNatus Medical Inc.
Medical DeviceJun 22, 2016
Datascope Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with recall — FDA Z-2002-2016
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceJun 22, 2016
Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV Introducer Kit under recall — FDA Z-1967-2016
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)-refurbished, R16650A A recall — FDA Z-1897-2016
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
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered recall — FDA Z-1990-2016
Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In…
Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation
Medical DeviceJun 22, 2016
Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve recall — FDA Z-1984-2016
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-1973-2016
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 TCA Board, 16542A A continuous ventilator intended to recall — FDA Z-1894-2016
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
Siemens Medical Solutions USA Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage recall — FDA Z-1998-2016
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
Zimmer Trabecular Metal Technology TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 recall — FDA Z-1952-2016
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
Ethicon EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd recall — FDA Z-1996-2016
Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the…
Class IIFDA: TerminatedEthicon, Inc.
Medical DeviceJun 22, 2016
Siemens Medical Solutions USA BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product recall — FDA Z-1999-2016
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
The Anspach Effort Universal Battery Charger II (UBC II) recall — FDA Z-1994-2016
The device is reported to enter safe mode and is no longer able to charge batteries.
Class IIFDA: TerminatedThe Anspach Effort, Inc.
Medical DeviceJun 22, 2016
Arthrex BioSync Anatomic Cotton Wedge, 16 x 4.5 mm recall — FDA Z-1958-2016
Potential for polystyrene particulate presence.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceJun 22, 2016
Navilyst Medical, Inc., an AngioDyamics Company BioFlo PICC with ENDEXO and PASV Valve recall — FDA Z-1981-2016
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 Standard with Compressor ventilator-refurbished recall — FDA Z-1893-2016
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
Sysmex The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated recall — FDA Z-1945-2016
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Class IIFDA: TerminatedSysmex Corporation
Medical DeviceJun 22, 2016
Miami Fat Supply The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2 recall — FDA Z-1957-2016
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Class IIFDA: TerminatedMiami Fat Supply, Inc.
Medical DeviceJun 22, 2016
Navilyst Medical, Inc., an AngioDyamics Company Vaxcel PICC with PASV MST-60 Kit under the recall — FDA Z-1970-2016
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 MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR recall — FDA Z-1953-2016
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 Vaxcel PICC with PASV Intermediate Safety recall — FDA Z-1972-2016
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
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.