Sterile Nail Clipper Concave Edge (67710)
Centurion Medical Products
Class I - Dangerous
Compromised seal on the sterile barrier pouch.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Class I - Dangerous
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class I - Dangerous
Affected products may have been manufactured with the catheter distal end hole too small
Class I - Dangerous
Affected products may have been manufactured with the catheter distal end hole too small
Class I - Dangerous
Packaged with an incorrect size inner cannula.
Class I - Dangerous
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Class I - Dangerous
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Class I - Dangerous
Certain lots were mislabeled with incorrect product number.
Product with incorrect shelf life.
Class I - Dangerous
The titanium implant has the wrong article number laser marked on it.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
User may suffer an electric shock when coming in contact with the exposed electronic components
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Flowonix Medical
Class I - Dangerous
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Microline Surgical
Class I - Dangerous
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
OriGen Biomedical
Class I - Dangerous
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Class I - Dangerous
Incorrect needle length and gage.
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Class I - Dangerous
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.