Class I - Dangerous
Charging base of surgical clippers overheats and smokes.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Potential breach of the sterile barrier packaging.
Class I - Dangerous
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Class I - Dangerous
Potential breach of the sterile barrier packaging.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Stryker Howmedica Osteonics
Class I - Dangerous
A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Merit Medical Systems
Class I - Dangerous
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.
The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Class I - Dangerous
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Class I - Dangerous
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Class I - Dangerous
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Class I - Dangerous
The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.