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Recall Observatory FDA recall evidence

Core noun

Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 12 of 3462

Product Firm Event Initiated
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure. Boston Scientific Corporation Event 98970 May 12, 2026
Octopus Evolution Tissue Stabilizer, Model TS2000 Medtronic Perfusion Systems Event 98966 May 12, 2026
Octopus 4 Tissue Stabilizer, Model 29400 Medtronic Perfusion Systems Event 98966 May 12, 2026
Octopus Evolution AS Tissue Stabilizer, Model TS2500 Medtronic Perfusion Systems Event 98966 May 12, 2026
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 ANI Pharmaceuticals, Inc. Event 98947 May 12, 2026
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. IntegraDose Compounding Services LLC Event 98991 May 12, 2026
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. Spectra Medical Devices, Llc Event 98976 May 12, 2026
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. SUN PHARMACEUTICAL INDUSTRIES INC Event 98921 May 12, 2026
STRAUS FAMILY CREAMERY Strawberry ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL) ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC for QUART: 784830100979 UPC for PINT: 784830100955 Straus Family Creamery Event 98982 May 12, 2026
STRAUS FAMILY CREAMERY Dutch Chocolate ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100122 Straus Family Creamery Event 98982 May 12, 2026
STRAUS FAMILY CREAMERY Mint Chip ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100504 Straus Family Creamery Event 98982 May 12, 2026
STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100306 Straus Family Creamery Event 98982 May 12, 2026
STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830101044 Straus Family Creamery Event 98982 May 12, 2026
Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland Dkiru LLC Event 98984 May 12, 2026
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. In2bones USA, LLC Event 98978 May 11, 2026
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A Inspire Medical Systems Inc. Event 98990 May 11, 2026
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A Inspire Medical Systems Inc. Event 98990 May 11, 2026
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device Boston Scientific Corporation Event 99063 May 11, 2026
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A Zimmer, Inc. Event 99073 May 11, 2026
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. Haleon US Holdings LLC Event 98910 May 11, 2026
HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz) Distributed by HH Fresh Trading Exported by JIA YANG INTERNATIONAL ENTERPRISES CO., LTD. Produced by Green Farm (Taiwan) UPC: 4711498860002 HH FRESH TRADING CORP Event 98993 May 11, 2026
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C AMD Medicom Inc. Event 99006 May 08, 2026
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance Datex-Ohmeda Inc Event 99036 May 08, 2026
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C AMD Medicom Inc. Event 99006 May 08, 2026
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance. Datex-Ohmeda Inc Event 99036 May 08, 2026