Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Health CanadaTransport Canada Recall - 2026270 - ALTEC INDUSTRIES
Transport Canada Recall - 2026270 - ALTEC INDUSTRIES
Electrical
Health CanadaCorNeat KPro
CorNeat KPro
Performance
Health CanadaTransport Canada Recall - 2026277 - VERMEER
Transport Canada Recall - 2026277 - VERMEER
Structure
Health CanadaHALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves
HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves
Performance
FDA DevicesMOSAIQ Oncology Information System
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA DevicesAllia IGS Pulse angiographic X-ray system
Allia IGS Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA DevicesHalyard, Pain Pack. Kit Code: AMPK48-01.
Halyard, Pain Pack. Kit Code: AMPK48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
FDA DevicesAllia Moveo angiographic X-ray system
Allia Moveo angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
FDA DevicesBrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
FDA DevicesHalyard, Towel Six Pack. Kit Code: AMTS70-01.
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
FDA DevicesProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA DevicesBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Due to incorrect incubation process being performed on product.
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
FDA FoodCake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodMarquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodFarm Rich Pizza Cheese Crunchers
Farm Rich Pizza Cheese Crunchers
May contain metal pieces
Australia ProductsBaby quilted printed snowsuit
Baby quilted printed snowsuit
The snaps fasteners on the snowsuits can detach during use.
FDA FoodMarquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Marquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
FDA FoodCake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980
Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Australia ProductsRAINS insulated stainless steel tumbler 450ml
RAINS insulated stainless steel tumbler 450ml
The lid may detach from the tumbler in certain situations when used.