Medical DeviceJul 19, 2017
AMS Diagnostics Medica ISE Module Calibrant A recall — FDA Z-2725-2017
Lot was not functioning properly and not exhibiting the correct physical properties.
Class IIIFDA: OngoingAMS Diagnostics, LLC
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 930
28,065 detailed records are currently available in this category.
Medical DeviceJul 19, 2017
ICU Medical 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating recall — FDA Z-2723-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJul 19, 2017
GE Healthcare Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 recall — FDA Z-2703-2017
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJul 19, 2017
Natus Medical The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for recall — FDA Z-2701-2017
Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology…
Class IIFDA: TerminatedNatus Medical Inc.
Medical DeviceJul 19, 2017
ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise recall — FDA Z-2679-2017
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Class IIFDA: TerminatedICU
Medical DeviceJul 19, 2017
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer recall — FDA Z-2699-2017
Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceJul 19, 2017
Natus Neurology Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300 recall — FDA Z-2728-2017
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Class IIFDA: TerminatedNatus Neurology Inc.
Medical DeviceJul 19, 2017
St. Jude Medical Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE recall — FDA Z-2691-2017
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Class IIFDA: TerminatedSt. Jude Medical, Inc.
Medical DeviceJul 19, 2017
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the recall — FDA Z-2730-2017
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceJul 19, 2017
ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise recall — FDA Z-2680-2017
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Class IIFDA: TerminatedICU
Medical DeviceJul 19, 2017
ICU Medical 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold recall — FDA Z-2717-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJul 19, 2017
bioMerieux VIDAS Testosterone, Ref 30418 recall — FDA Z-2339-2017
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Class IIFDA: TerminatedbioMerieux, Inc.
Medical DeviceJul 19, 2017
ICU Medical 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 recall — FDA Z-2718-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJul 19, 2017
ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise recall — FDA Z-2682-2017
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Class IIFDA: TerminatedICU
Medical DeviceJul 19, 2017
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS recall — FDA Z-2705-2017
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
Class IIFDA: TerminatedO-Two Medical Technologies, Inc.
Medical DeviceJul 19, 2017
Pentax of Video Duodenoscope These instruments are intended to provide optical visualization recall — FDA Z-2713-2017
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the…
Class IIFDA: TerminatedPentax of America Inc.
Medical DeviceJul 19, 2017
Exactech Optetrak Logic CC 15mm Tibial Augment Screws recall — FDA Z-2704-2017
Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceJul 19, 2017
Natus Neurology Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog recall — FDA Z-2726-2017
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Class IIFDA: TerminatedNatus Neurology Inc.
Medical DeviceJul 19, 2017
ICU Medical 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve recall — FDA Z-2719-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJul 19, 2017
ICU The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise recall — FDA Z-2678-2017
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Class IIFDA: TerminatedICU
Medical DeviceJul 19, 2017
ICU Medical 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve recall — FDA Z-2716-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJul 19, 2017
O-Two Medical Technologies Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 recall — FDA Z-2731-2017
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn…
Class IIFDA: TerminatedO-Two Medical Technologies, Inc.
Medical DeviceJul 19, 2017
Toshiba American Medical Systems XARIO 100 TUS-X100 diagnostic ultrasound system recall — FDA Z-2708-2017
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the…
Class IIFDA: TerminatedToshiba American Medical Systems Inc.
Medical DeviceJul 19, 2017
ICU Medical 10" Smallbore Ext Set w/6-Port NanoClave Manifold recall — FDA Z-2722-2017
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
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.