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CriticalCPSC
Amazon From May 2024 Through April 2025 For About $20.
Youbeien Crib Mobiles Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates the Mandatory Toy Standard for Batteries; Sold on Amazon by GKKBSJ
Toys·3,000 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 20lb and 18lb bulk "Fifth Avenue" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 15lb bulk "Madison" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 15lb bulk "Broadway" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 20lb bulk "Park" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 18lb bulk "Empire" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Goyal Group Inc.
1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches
Dairy·293 affected·Sep 18, 2025
CriticalFDA
Garden Fresh Foods, Inc.
Sliced (1/4") green onions, refrigerated, packaged in plastic bag. Each case consist 5/6lbs. bag (net wt. 30lbs.). Garden Fresh Foods Inc...
Produce·540 affected·Sep 18, 2025
CriticalFDA
Western United Fish Company Inc
Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193, net wt. 1lb. Product is packaged in clear plastic clamshell container and s...
Seafood·3,314 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Medical Devices·31 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed ...
Surgical Devices·48,110 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" S...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 118026441...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm...
Surgical Devices·60 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) ...
Surgical Devices·2,840 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed t...
Surgical Devices·0 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (1...
Surgical Devices·10,130 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux...
Medical Devices·0 affected·Sep 18, 2025
CriticalFDA
Cook Medical Incorporated
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167...
Medical Devices·695 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Spring...
Surgical Devices·0 affected·Sep 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for O...
Medical Devices·833 affected·Sep 18, 2025
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Medical Devices·51,144 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP....
Medical Devices·5,770 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Medical Devices·37 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PE...
Surgical Devices·2,760 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWEN...
Medical Devices·2,450 affected·Sep 18, 2025
CriticalFDA
D & M Smoked Fish, Inc.
Haifa COLD SMOKED SALMON 8 OZ.
Seafood·2,022 affected·Sep 17, 2025
High RiskFDA
Pepsico Inc
Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "*** Lipton Green Tea Citrus (25g sugar)***" In...
Beverages·2,854 affected·Sep 17, 2025
CriticalFDA
D & M Smoked Fish, Inc.
Haifa COLD SMOKED SEABASS 8 OZ
Food·348 affected·Sep 17, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403...
Topical Drugs·13,824 affected·Sep 17, 2025
High RiskFDA
Park Avenue Compounding
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, ND...
Drugs·858 affected·Sep 17, 2025
High RiskFDA
Baxter Healthcare Corporation
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermomete...
Medical Devices·5,209 affected·Sep 17, 2025
High RiskFDA
Cpm Medical Consultants, Llc.
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, ...
Medical Devices·3,317 affected·Sep 17, 2025
CriticalFDA
Percussionaire Corporation
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Val...
Respiratory Devices·59,160 affected·Sep 17, 2025
High RiskFDA
Enterix, Inc.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure O...
Medical Devices·201,426 affected·Sep 17, 2025
High RiskFDA
Sprout Organics Inc.
6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGAN...
Beverages·9,873 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. ...
Seafood·8,400 affected·Sep 16, 2025
RecallFDA
Gansu Zhaofeng Agricultural Development Co., Ltd.
G&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C wa...
Beverages·42,552 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised...
Seafood·4,871 affected·Sep 16, 2025
CriticalFDA
Integradose Compounding Services Llc
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, M...
Injectable Drugs·853 affected·Sep 16, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, ...
Oral Drugs·54,432 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Devices·45 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological sy...
Surgical Devices·19 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product ...
Medical Devices·9,177 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·17 affected·Sep 16, 2025