Class I - Dangerous
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Myco Medical Supplies
Class I - Dangerous
Particulates: Complaints of rubber coring from the closure of injection vials.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
Stryker Instruments Div. of Stryker
Class I - Dangerous
The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class I - Dangerous
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
Class I - Dangerous
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
LeMaitre Vascular
Class I - Dangerous
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.