Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,115 results
Medical Device
FDA Devices
FDA DevicesBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific Neuromodulation Corporation
FDA DevicesClass II
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
Jun 17, 2026Boston Scientific Neuromodulation Corporation
Medical DeviceFDA Devices
FDA DevicesAllia Moveo angiographic X-ray system
GE Medical Systems, LLC
FDA DevicesClass II
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.
Jun 17, 2026GE Medical Systems, LLC
Medical DeviceFDA Devices
FDA DevicesHalyard, Pain Pack. Kit Code: AMPK48-01.
AVID Medical, Inc.
FDA DevicesClass II
Halyard, Pain Pack. Kit Code: AMPK48-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Jun 17, 2026AVID Medical, Inc.
Medical DeviceFDA Devices
FDA DevicesProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Avanos Medical, Inc.
FDA DevicesClass II
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Jun 17, 2026Avanos Medical, Inc.
Medical DeviceFDA Devices
FDA DevicesMOSAIQ Oncology Information System
Elekta, Inc.
FDA DevicesClass II
MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Jun 17, 2026Elekta, Inc.
Medical DeviceFDA Devices
FDA DevicesProduct Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Avanos Medical, Inc.
FDA DevicesClass II
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.
Jun 17, 2026Avanos Medical, Inc.
Medical DeviceFDA Devices
FDA DevicesHalyard, Drape Pack. Kit Code: LMDP36-01.
AVID Medical, Inc.
FDA DevicesClass II
Halyard, Drape Pack. Kit Code: LMDP36-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Jun 17, 2026AVID Medical, Inc.
Medical DeviceFDA Devices
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
HF Acquisition Co LLC
FDA DevicesClass II
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.
Jun 17, 2026HF Acquisition Co LLC
Medical DeviceFDA Devices
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.
The Binding Site Group, Ltd.
FDA DevicesClass II
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.
Jun 17, 2026The Binding Site Group, Ltd.
Food & BeverageFDA Food
FDA FoodFarm Rich Pizza Cheese Crunchers
Rich Products Corp
FDA FoodClass II
Farm Rich Pizza Cheese Crunchers
May contain metal pieces
Jun 17, 2026Rich Products Corp
Food & BeverageFDA Food
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
Galaxy RG Corp
FDA FoodClass II
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).
Jun 17, 2026Galaxy RG Corp
Food & BeverageFDA Food
FDA FoodJumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Galaxy RG Corp
FDA FoodClass II
Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Jun 17, 2026Galaxy RG Corp
Safety Alert
Australia Products
Australia ProductsBaby quilted printed snowsuit
Unknown Firm
Australia ProductsClothing (daywear)
Baby quilted printed snowsuit
The snaps fasteners on the snowsuits can detach during use.
Jun 17, 2026
Food & BeverageFDA Food
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
Galaxy RG Corp
FDA FoodClass II
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).
Jun 17, 2026Galaxy RG Corp
Safety AlertAustralia Products
Australia ProductsRAINS insulated stainless steel tumbler 450ml
Unknown Firm
Australia ProductsKitchenware and...
RAINS insulated stainless steel tumbler 450ml
The lid may detach from the tumbler in certain situations when used.
Jun 17, 2026
Food & BeverageFDA Food
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
Galaxy RG Corp
FDA FoodClass II
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).
Jun 17, 2026Galaxy RG Corp
Medical DeviceFDA Devices
FDA DevicesMedartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Medartis AG
FDA DevicesClass II
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
The cannulation of the CCS screw is not centered.
Jun 17, 2026Medartis AG
Medical DeviceFDA Devices
FDA DevicesCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
INSPIREMD Inc
FDA DevicesClass II
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Jun 17, 2026INSPIREMD Inc
Food & BeverageFDA Food
FDA FoodCheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Galaxy RG Corp
FDA FoodClass II
Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Jun 17, 2026Galaxy RG Corp
PharmaceuticalFDA Drugs
FDA DrugsZep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Zep Inc
FDA DrugsClass II
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.
Microbial contamination of sterile products
Jun 17, 2026Zep Inc
Medical DeviceFDA Devices
FDA DevicesEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
BERLIN HEART GMBH
FDA DevicesClass II
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Jun 17, 2026BERLIN HEART GMBH
PharmaceuticalFDA Drugs
FDA DrugsEpinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Fresenius Kabi USA, LLC
FDA DrugsClass III
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Failed Impurities/Degradations Specifications
Jun 17, 2026Fresenius Kabi USA, LLC
Medical DeviceFDA Devices
FDA DevicesBrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
INSPIREMD Inc
FDA DevicesClass II
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Jun 17, 2026INSPIREMD Inc
Food & BeverageFDA Food
FDA FoodCake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a plastic container, one unit per container. KEEP REFRIGERATED. UPC 824790852782
Galaxy RG Corp
FDA FoodClass II
Cake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a plastic container, one unit per container. KEEP REFRIGERATED. UPC 824790852782
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Jun 17, 2026Galaxy RG Corp