Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesSurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Food2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.
2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.
Potential presence of Salmonella.
RappelConsoles moulinettes - penne betteraves
les moulinettes - penne betteraves
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
FDA FoodJoy Mint Lassi 16 oz.
Joy Mint Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DevicesMedline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
FDA DevicesSurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
UK FSAO’Brien Fine Foods recalls ham products because of possible contamination with Listeria monocytogenes
O’Brien Fine Foods recalls ham products because of possible contamination with Listeria monocytogenes
The possible presence of Listeria monocytogenes in the products listed above. Symptoms caused by Listeria monocytogenes can be similar to flu and include high temperature, muscle ache or pain, chills, feeling or being sick and diarrhoea. However, in rare cases, the infection can be more severe, causing serious complications, such as meningitis. Some people are more vulnerable to listeria infections, including those over 65 years of age, pregnant women and their unborn babies, babies less than one month old and people with weakened immune systems.
FDA DevicesDa Vinci ASSY, PSS, SP1098, Part Number: 380601
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DevicesOctopus 4 Tissue Stabilizer, Model 29400
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DrugsBD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA FoodRoast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***"
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***"
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
AustraliaITCHA SSS capsules
ITCHA SSS capsules
We are advising consumers that ITCHA SSS capsules, marketed for weight management, have been found to contain oxedrine, an undisclosed prescription-only medicine....
FDA DrugsSensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
CGMP Deviations
FDA DevicesAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Potential for thrombus formation during prolonged use of the introducer.
FDA DevicesSurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Potential for thrombus formation during prolonged use of the introducer.
FDA Foodboichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
FDA DevicesOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA DrugsSensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
CGMP Deviations
FDA DevicesThuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.