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.
23,781 detailed records are currently available in this category.
Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the…
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to…
Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is…
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the…
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to…
Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to…
Sterile extension sets were distributed without an expiration date
Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump…
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the…
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product…
Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump…
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide…
Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or…
Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed…
After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be…
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.
