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Recall Observatory FDA recall evidence

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Recalled products

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

Indexed record set

86,536 products

Page 74 of 3462

Product Firm Event Initiated
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 Howmedica Osteonics Corp. Event 98411 February 02, 2026
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A B Braun Medical Inc Event 98380 February 02, 2026
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A B Braun Medical Inc Event 98380 February 02, 2026
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A B Braun Medical Inc Event 98380 February 02, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 Pro Numb Tattoo Numbing Spray LLC Event 98361 February 02, 2026
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 Pro Numb Tattoo Numbing Spray LLC Event 98361 February 02, 2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 On-X Life Technologies, Inc. Event 98548 February 01, 2026
Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA. Costco Wholesale Corporation Event 98375 January 31, 2026
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013 GE Medical Systems, LLC Event 98428 January 30, 2026
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 GE Medical Systems, LLC Event 98428 January 30, 2026
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906 GE Medical Systems, LLC Event 98428 January 30, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). Covidien LLC Event 98407 January 30, 2026
DxC 700 AU, REF: B86444, B86446 Beckman Coulter Mishima K.K. Event 98346 January 30, 2026
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 Medline Industries, LP Event 98437 January 30, 2026
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 Beckman Coulter Mishima K.K. Event 98346 January 30, 2026
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 Medtronic MiniMed, Inc. Event 98444 January 30, 2026
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Tandem Diabetes Care, Inc. Event 98478 January 30, 2026
Karns Foods, Mini Dark Chocolate Raspberry Cups, 8 oz Clear plastic tamper evident packs, 36-42 packed per breakout Karns Prime And Fancy Foods Event 98377 January 30, 2026
The Tuna Salad product container is mislabeled with a Chicken Salad lid, which states: Molly Kitchen's Chicken Salad, 789953, NET WT. 5 LB (2.26 kg) per plastic tub. UPC 7 5810830149 8. Distributed by US Foods, Inc. Rosemont, IL 60018. The lid declares Contains: Eggs, Milk, Wheat. The immediate 5-lb tub has no side labeling (besides the lid). The master cardboard case label is correct and states: Molly Kitchen's Tuna Salad, (item #) 794599, 2/5 LB tubs per case, Net Wt. 10 LB (4.53 kg). UPC 075810876447. Distributed by US Foods, Inc. Rosemont, IL 60018. Contains: Egg, Wheat, Fish (Tuna). Reser's Fine Foods, Inc. Event 98381 January 30, 2026
Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***" J2C Hawaii LLC Event 98373 January 30, 2026
Taro Cakes UPC CODE #652565100055 E & S Grocery & Bakery Inc. Event 98369 January 30, 2026
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. Olympus Corporation of the Americas Event 98240 January 29, 2026
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. Olympus Corporation of the Americas Event 98240 January 29, 2026
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation ReCor Medical Inc. Event 98365 January 29, 2026
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation ReCor Medical Inc. Event 98365 January 29, 2026

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