Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
MEDLINE INDUSTRIES, LP - Northfield
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
MEDLINE INDUSTRIES, LP - Northfield
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Medical Action Industries, Inc. 306
The kits contain saline flush syringes which were recalled by the supplier.
stay-safe /Luer Lock Catheter Ext. 18 in
Fresenius Medical Care Holdings
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
stay-safe /Luer Catheter Ext. 6 in
Fresenius Medical Care Holdings
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
stay-safe /Luer Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
stay-safe /Safe Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos International Sarl
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
EasyPoint Needle, 25G x 5/8", REF: 82091
Retractable Technologies
The needle cannula of a retractable needle may detach from the needle holder in the patient.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
MEDLINE INDUSTRIES, LP - Northfield
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.