Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class I - Dangerous
Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Class I - Dangerous
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Class I - Dangerous
Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Class I - Dangerous
Product labeling does not match product configuration.
ORCHESTRA/ORCHESTRA PLUS Programmer
Sorin Group Italia S.r.l.
Class I - Dangerous
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
Class I - Dangerous
Product labeling does not match product configuration.
VITROS Chemistry Products COCM Reagent
Ortho-Clinical Diagnostics
Class I - Dangerous
Inaccurate quality control results.
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Philips Medical Systems (Cleveland)
Class I - Dangerous
The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.
Class I - Dangerous
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
Class I - Dangerous
In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Churchill Medical Systems
Class I - Dangerous
Defective component may cause extension sets to leak.
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
Some carbide cutting burr fractured during use.
Class I - Dangerous
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Class I - Dangerous
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Class I - Dangerous
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Class I - Dangerous
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide