Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Class I - Dangerous
The devices may not meet the minimum required sterility assurance level.
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Normand-Info S.A.S.U.
Class I - Dangerous
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.
Class I - Dangerous
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Class I - Dangerous
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Class I - Dangerous
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Smiths Medical ASD
Class I - Dangerous
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
Class I - Dangerous
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
MARVAO MEDICAL DEVICES
Class I - Dangerous
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
BIOPSYBELL S.R.L.
Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock