Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
30,447 detailed records are currently available in this category.
There is a potential for patient finger injury on the e.cam systems.
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as…
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the…
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during…
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related…
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts…
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the…
Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed…
Use of excessive force when impacting may lead to intra-operative femoral fracture.
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
