Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DrugsDabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
FDA DevicesSnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
FDA DevicesFARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA DevicesP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
FDA DevicesMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
FSANZ FoodAuxico (Perth) Pty Ltd - LGM HOT CHILLI OIL 275G
Auxico (Perth) Pty Ltd - LGM HOT CHILLI OIL 275G
The recall is due to the presence of an undeclared allergen (peanuts).
FDA DevicesPower F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
FDA DrugsDivalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Presence of Foreign Tablets/Capsules
FDA DevicesFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
FDA FoodFusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw .
Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw .
Undeclared Allergen (Fish)
FDA DevicesFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
FDA Food1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams
1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams
Contaminated with Salmonella
FDA FoodIsland Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748
Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748
Undeclared sodium tripolyphosphate (STTP)
FDA FoodNAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744
NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744
Undeclared sodium tripolyphosphate (STTP)
Australia ProductsThe Dot Space laser cat toy
The Dot Space laser cat toy
The cat toy doesn’t comply with the mandatory standards for products containing button/coin batteries . The battery isn’t secured, and children could access the button/coin battery. The screw isn’t secured to the battery covering and could be lost when replacing the battery.
RappelConsoandre loussouarn - museau vinaigrette
andre loussouarn - museau vinaigrette
contamination microbiologique
RappelConsocréa maison - viandes marinées paprika
créa maison - viandes marinées paprika
l'analyse d'un échantillon de viande marinée au paprika a révélé la présence de salmonelle.
RappelConsosans marque - fourme de montbrison aop
sans marque - fourme de montbrison aop
présence de listeria monocytogenes
Australia ProductsCrazer LED light show toy - 5 Images
Crazer LED light show toy - 5 Images
The cat toy doesn’t comply with the mandatory standards for products containing button/coin batteries . The battery isn’t secured, and children could access the button/coin battery. The screw isn’t secured to the battery covering and could be lost when replacing the battery.
Germany BVLGeriebene Mandeln 200 Gramm
Geriebene Mandeln 200 Gramm
Krankheitserreger
RappelConsopas de marque - 629888 mug email por 350ml d9,4
pas de marque - 629888 mug email por 350ml d9,4
ces produits représentent un risque pour la santé en raison de la présence en concentration trop élevée de certaines substances chimiques ex : le cobalt.
RappelConsoprestige de la sarthe - epaule de porc cuite
prestige de la sarthe - epaule de porc cuite
suspicion de listeria monocytogenes
RappelConsoprestige de la sarthe - produits de charcuterie congeles
prestige de la sarthe - produits de charcuterie congeles
suspicion de listeria monocytogenes
RappelConsol'italie des saveurs - tramezzino kebab 150g
l'italie des saveurs - tramezzino kebab 150g
suspicion présence listéria