Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1630

The newest recall records with useful source details are listed here.

Medical DeviceMay 31, 2017

Cardiovascular Systems CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only recall — FDA Z-2122-2017

Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The…

Class IIFDA: TerminatedCardiovascular Systems Inc.

Medical DeviceMay 31, 2017

Merge Cardio software recall — FDA Z-2123-2017

Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting…

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceMay 31, 2017

EBI Patient Care 10-1398M - SpF-PLUS Implantable Stimulator recall — FDA Z-2119-2017

Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels…

Class IFDA: TerminatedEBI Patient Care, Inc.

Medical DeviceMay 31, 2017

Stryker Howmedica Osteonics Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm recall — FDA Z-2160-2017

Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended…

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceMay 31, 2017

Thoratec HeartMate II LVAS with Pocket Controller recall — FDA Z-2053-2017

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This…

Class IFDA: TerminatedThoratec Corporation

Medical DeviceMay 31, 2017

B Braun Medical CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units recall — FDA Z-2155-2017

B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.

Class IIFDA: TerminatedB Braun Medical Inc.

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR recall — FDA Z-2131-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Teleflex Medical PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter recall — FDA Z-2128-2017

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR recall — FDA Z-2136-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Silicone Round Drain, 7FR recall — FDA Z-2145-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Beckman Coulter Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA recall — FDA Z-2124-2017

Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceMay 31, 2017

CORPAK MedSystems CORFLO PEG Kit, Pull 16FR recall — FDA Z-2163-2017

Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

Class IIFDA: TerminatedCORPAK MedSystems, Inc.

Medical DeviceMay 31, 2017

Medtest Holdings Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial recall — FDA Z-2121-2017

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Class IIIFDA: TerminatedMedtest Holdings, Inc.

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Silicone Round Drain, 15FR recall — FDA Z-2147-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Medtronic Inc., Cardiac Rhythm and Heart Failure Amplia MRI Quad CRT-0 SureScan Claria MRI recall — FDA Z-2117-2017

An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

Class IIFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Silicone Round Drain, 19FR recall — FDA Z-2148-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Hemaduct Silicone Flat Drain recall — FDA Z-2132-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts recall — FDA Z-2144-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt PVC Round Drain, 10FR W/Trocar recall — FDA Z-2140-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

Medical DeviceMay 31, 2017

Cardinal Health 200 Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts recall — FDA Z-2141-2017

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Class IIFDA: TerminatedCardinal Health 200, LLC

FoodMay 31, 2017