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.
Potentially Biased Results using VITROS Chemistry Products GLU Slides
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.…
Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only…
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
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.…
Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only…
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Potential for sterile packaging to be compromised
Potential for sterile packaging to be compromised
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
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…
Potential for sterile packaging to be compromised
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one…
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Potential for sterile packaging to be compromised
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
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.
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
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…
Failure to comply event due to incorrect labeling of a class 1 laser product.
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.
