Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1756

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

Medical DeviceNov 23, 2016

Atrium Medical 12 Fr Trocar catheter, Sterile recall — FDA Z-0578-2017

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceNov 23, 2016

Philips Medical Systems (Cleveland) Ingenuity CT Computed Tomography X-ray system, Model recall — FDA Z-0595-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

Philips Medical Systems (Cleveland) Ingenuity Core 128 Computed Tomography X-ray system recall — FDA Z-0596-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac recall — FDA Z-0423-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable recall — FDA Z-0487-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED recall — FDA Z-0522-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush recall — FDA Z-0550-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 recall — FDA Z-0461-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV recall — FDA Z-0493-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Sorin Group USA The ORCHESTRA Programmer A portable device, equipped with a microprocessor recall — FDA Z-0412-2017

Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceNov 23, 2016

Atrium Medical 28 Fr Trocar catheter, Sterile recall — FDA Z-0582-2017

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceNov 23, 2016

ICU Medical TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS recall — FDA Z-0498-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 recall — FDA Z-0483-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical 4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS recall — FDA Z-0532-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 recall — FDA Z-0490-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item recall — FDA Z-0508-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item recall — FDA Z-0515-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Roche Diagnostics Operations Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog recall — FDA Z-0395-2017

Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceNov 23, 2016

C.R. Bard Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil recall — FDA Z-0403-2017

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Class IIFDA: TerminatedC.R. Bard, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 recall — FDA Z-0444-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item recall — FDA Z-0504-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical 5 Port "OFF" Manifold w/TRANSPAC IV, Item No. 46100-29 The Transpac Disposable recall — FDA Z-0539-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo Flush recall — FDA Z-0546-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 recall — FDA Z-0518-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

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