Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1760

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

Medical DeviceNov 23, 2016

ICU Medical Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush recall — FDA Z-0543-2017

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

Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test) recall — FDA Z-0398-2017

Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceNov 23, 2016

ICU Medical Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The recall — FDA Z-0528-2017

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 SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. recall — FDA Z-0484-2017

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

Alphatec Spine Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage recall — FDA Z-0592-2017

Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

Class IIFDA: TerminatedAlphatec Spine, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT recall — FDA Z-0551-2017

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 Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The recall — FDA Z-0564-2017

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

C.R. Bard BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R recall — FDA Z-0404-2017

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

Atrium Medical 16 Fr Trocar catheter recall — FDA Z-0579-2017

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 TRANSPAC IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable recall — FDA Z-0422-2017

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

Philips Medical Systems (Cleveland) Brilliance iCT Computed Tomography X-ray system, Model recall — FDA Z-0593-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

ICU Medical CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. recall — FDA Z-0502-2017

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 DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac recall — FDA Z-0419-2017

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 SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" recall — FDA Z-0449-2017

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/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. recall — FDA Z-0548-2017

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 w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE recall — FDA Z-0520-2017

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

OMNI LIFE SCIENCE OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS recall — FDA Z-0610-2017

Incorrect lot number on outer kit

Class IIIFDA: TerminatedOMNI LIFE SCIENCE

Medical DeviceNov 23, 2016

ICU Medical CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable recall — FDA Z-0507-2017

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/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way recall — FDA Z-0554-2017

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 TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML recall — FDA Z-0434-2017

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 Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial recall — FDA Z-0560-2017

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 Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set recall — FDA Z-0541-2017

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 #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac recall — FDA Z-0466-2017

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 W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No recall — FDA Z-0574-2017

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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