Potential for compromise of the package resulting in a breach of the sterile barrier
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
Potential for compromise of the package resulting in a breach of the sterile barrier
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
Class I - Dangerous
Cracks may occur at the 15mm and 22mm ISO female connector.
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Zimmer Biomet Spine
Class I - Dangerous
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
Dako Denmark A/S
Class I - Dangerous
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.