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.
26,155 detailed records are currently available in this category.
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
Manufacturing flaw in the sterile barrier system
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
Potential for sterile packaging to be compromised
There was a higher than normal incidence rate of the blade not retracting when tightening.
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Potential for sterile packaging to be compromised
Potential for sterile packaging to be compromised
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing…
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera…
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated.…
Potential for sterile packaging to be compromised
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range;…
A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
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.
