Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Collagen Matrix
Class I - Dangerous
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
AROA Biosurgery
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Class I - Dangerous
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Class I - Dangerous
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Medtronic CareLink Encore 29901 Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
Liquid Cardiac Control, CQ5053
Randox Laboratories
Class I - Dangerous
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Safe N Simple
Class I - Dangerous
The sterilization process used was unqualified.
Class I - Dangerous
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Medtronic CareLink 2090 Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
Liquid Cardiac Control, CQ5052
Randox Laboratories
Class I - Dangerous
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Liquid Cardiac Control, CQ5051
Randox Laboratories
Class I - Dangerous
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Class I - Dangerous
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.