Complete FDA and NHTSA recall records dated in 2018, 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.
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had…
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
The Internal packaging, the pouch and patient labels are improperly labeled.
Device may display a battery missing error.
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that…
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an…
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had…
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were…
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system…
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error,…
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
The product label has missing information, such as the lot number and expiration date, as well as other information.
The main vial label lists the incorrect part number, but the cap label is correct.
Potential to contain metal fragments
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.
