Home › Medical Device Recalls

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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1011

28,535 detailed records are currently available in this category.

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 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 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 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

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 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

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 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 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 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

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 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

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

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

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

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

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 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

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

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 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

Merge PACS software recall — FDA Z-0599-2017

The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device recall — FDA Z-0567-2017

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 CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. recall — FDA Z-0481-2017

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.

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.