Reports of various packaging issues that may result in a breach of the sterile barrier.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Cook Biotech
Class I - Dangerous
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class I - Dangerous
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Boston Scientific
Class I - Dangerous
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
CareFusion 303
Class I - Dangerous
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
Class I - Dangerous
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics
Class I - Dangerous
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
8MM,FORCE BIPOLAR,IS4000 REF 471405
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Sklar Instruments
Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
Class I - Dangerous
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management
Class I - Dangerous
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Mercury Enterprises, Inc.
Class I - Dangerous
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.