Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Ortho-Clinical Diagnostics
Class I - Dangerous
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
LPS-MOB ART SURF IMPL D 9MM
Zimmer Biomet
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
Class I - Dangerous
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Argon Medical Devices
Class I - Dangerous
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Insulet
Class I - Dangerous
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Prismaflex Control Unit, software versions below 7.21
Baxter Healthcare
Class I - Dangerous
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Centurion Medical Products
Class I - Dangerous
Sterile packaging incomplete seals may compromise sterility of the product