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.
21,924 detailed records are currently available in this category.
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the…
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Complaints have been received regarding post-operative implant collapse.
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required…
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the…
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the…
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue…
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the…
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation…
Lack of 510(k) clearance.
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice…
Potential for hole in package compromising sterility of the medical kit.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice…
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.
