Latest recalls — page 130
Older notices, newest first.
-
Class I · 6 months ago
pork rinds and seasoning bottles recall: Potential Foodborne Illness - Salmonella
Potential Foodborne Illness - Salmonella
-
Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
-
Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
-
Class II · 6 months ago
Medline Kits: 1) Arthrogram Tray recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
-
Class II · 6 months ago
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall: The catheter inflation tag attached to the device may contain an incorrect
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures…
-
Class II · 6 months ago
Medline Kits: 1) D AND C PACK recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
-
Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
XTANT Medical Holdings, Inc nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus recall: Products were incorrectly labeled with a 5-year shelf life. The approved
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
-
Class II · 6 months ago
Angiodynamics, Inc. Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
Remel Europe Ltd. Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 recall: Affected lots are not performing to IFU criteria showing cross reactions
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the…
-
Class II · 6 months ago
Medline Kits: 1) Angio Cath Pack-Mary Immaculat recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
-
Class II · 6 months ago
Sequencing Agent SEQ0067, component of FoundationOne CDx recall: Possible increase in phasing, potentially resulting in false-positive BARD1
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
-
Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
-
Class II · 6 months ago
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use recall: Due to receiving a notice from a supplier that the liquid adhesive
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
-
Class II · 6 months ago
Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS recall: The product correction was initiated because B Braun is issuing a voluntary
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as…
-
Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
-
Class II · 6 months ago
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code recall: Due to receiving a notice from a supplier that the liquid adhesive
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
-
Class II · 6 months ago
Angiodynamics, Inc. AccuVu Angiographic Catheter, Omni Flush, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
Medline Kits: 1) Picc Tray recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
-
Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Sos Omni Selective , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
-
Class II · 6 months ago
Uvlizer c/o RAIS INTERNATIONAL LLC The product is a handheld ultraviolet-C germicidal recall: In some foreseeable use conditions, the Products can expose nearby persons
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by…
-
Class II · 6 months ago
SurgiSmoke Solutions Flamingo Funnel Large recall: Certain lots of product were associated with a manufacturing nonconformance
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.