Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.
Class I - Dangerous
The double swivel connector may crack or separate on the endobronchial tube.
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Class I - Dangerous
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Siemens Medical Solutions USA
Class I - Dangerous
Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
Class I - Dangerous
There is a potential the sling loops may not stay attached to the carry bar hooks.
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort
Class I - Dangerous
G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
Class I - Dangerous
Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
EXP Pharmaceutical Services
Class I - Dangerous
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
EXP Pharmaceutical Services
Class I - Dangerous
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
Class I - Dangerous
There is a potential the sling loops may not stay attached to the carry bar hooks.
Class I - Dangerous
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Gardner Denver Thomas
Class I - Dangerous
Vacuum pump may not perform to specification.
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Hitachi America, Ltd., Power Systems Division
Class I - Dangerous
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
Gardner Denver Thomas
Class I - Dangerous
Vacuum pump may not perform to specification.
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
Gardner Denver Thomas
Class I - Dangerous
Vacuum pump may not perform to specification.
Class I - Dangerous
Devon Light Gloves contain splits or holes compromising the sterility
Class I - Dangerous
Incorrect thread form on the screw.