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.
1,218 detailed records are currently available in this category.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A)…
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include…
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of…
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually…
Surgical dressing manufactured out of specification (greater thickness).
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general…
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
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.
