Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Class I - Dangerous
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Class I - Dangerous
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Medtronic Neuromodulation
Class I - Dangerous
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.
Comprehensive RS Cleat CAP, Item No. 110300
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Vital Scientific N.V.
Class I - Dangerous
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer be able to guarantee temperature control at full power.
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. 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).
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.
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
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Thermo Fisher Scientific (Monterrey)
Class I - Dangerous
Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.