This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.
All Recalls
95,102 total recalls in our database
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Innokas Medical Oy
🏥 Medical Devices Class I - Dangerous
Monitor may shut down unintentionally without restarting.
🏥 Medical Devices Class I - Dangerous
It was reported that packaging was not properly sealed.
🏥 Medical Devices Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
🏥 Medical Devices Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
🏥 Medical Devices Class I - Dangerous
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
🏥 Medical Devices Class I - Dangerous
Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.
Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.
🏥 Medical Devices Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
🏥 Medical Devices Class I - Dangerous
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Ceterix Orthopedics
🏥 Medical Devices Class I - Dangerous
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Stryker Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
🏥 Medical Devices Class I - Dangerous
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.