🏥 Medical Devices Class I - Dangerous
Sterile drapes packaged in an unsealed pouch.
All Recalls
95,114 total recalls in our database
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Abbott Laboratories
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.
🏥 Medical Devices 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
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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
One lot of INBONE Tibial Trays is missing the plasma coating.
🏥 Medical Devices Class I - Dangerous
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Incorrect expiration date on introduction cannula packaging.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
During an FDA audit, it was discovered that the product was not properly registered with FDA.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.