Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Abbott Laboratories
Class I - Dangerous
Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
Trilliant Surgical
Class I - Dangerous
Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
Class I - Dangerous
One lot of INBONE Tibial Trays is missing the plasma coating.
Class I - Dangerous
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Class I - Dangerous
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Class I - Dangerous
Incorrect expiration date on introduction cannula packaging.
Class I - Dangerous
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
Class I - Dangerous
Incorrect expiration date on introduction cannula packaging.
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
Delfi Medical Innovations
Class I - Dangerous
Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class I - Dangerous
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Northgate Technologies
Class I - Dangerous
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Philips North America
Class I - Dangerous
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Class I - Dangerous
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts