The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
All Recalls
95,064 total recalls in our database
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Mitek Screw and Washer Depth Gauge, Product Code 219024
DePuy Mitek, Inc., a Johnson & Johnson
🏥 Medical Devices Class I - Dangerous
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Alcon Research
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
🏥 Medical Devices Class I - Dangerous
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
MyLab Gamma, Model 7410
ESAOTE S.P.A.
🏥 Medical Devices Class I - Dangerous
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Alcon Research
🏥 Medical Devices Class I - Dangerous
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Product was released to market without the adulteration strip included in the product.
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
🏥 Medical Devices Class I - Dangerous
When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
Custom Healthcare Systems
🏥 Medical Devices Class I - Dangerous
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
MyLab Alpha, Model 7400
ESAOTE S.P.A.
🏥 Medical Devices Class I - Dangerous
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
🏥 Medical Devices Class I - Dangerous
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
🏥 Medical Devices Class I - Dangerous
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
🏥 Medical Devices Class I - Dangerous
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.