Complete FDA and NHTSA recall records dated in 2023, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive…
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive…
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
There is a potential that valve assemblies will not open. preventing fluid from draining.
The threads on posts stripping out when tensioned during application process.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may…
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder…
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for…
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the…
There is a potential that valve assemblies will not open. preventing fluid from draining.
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical…
There is a potential that valve assemblies will not open. preventing fluid from draining.
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
