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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Signal Medical

Class I - Dangerous

Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.

Feb 20, 2017 Other Medical Devices Nationwide View Details →

Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Alcon Research

Class I - Dangerous

Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.

Mar 27, 2017 Other Medical Devices Nationwide View Details →

Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.

Avid Medical

Class I - Dangerous

Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained and corrected. A full inventory analysis was conducted reviewing all vacutainer component inventories. The issue was found to affect a total of five vacutainer components.

Mar 15, 2017 Diagnostic Equipment View Details →

UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039

Philips Electronics North America

Class I - Dangerous

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Mar 22, 2017 Other Medical Devices Nationwide View Details →

Merge Eye Station and Merge Eye Care PACS.

Merge Healthcare

Class I - Dangerous

During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

Apr 4, 2016 Other Medical Devices Nationwide View Details →