FDA recalls, May 2026: 499 published

138 different companies appear this month.

Risk classification: Class I: 95 · Class II: 386 · Class III: 18

Same month, other agencies:CPSC 41 recallsFSIS 3 recallsNHTSA 81 recalls

Recalls this month

DateProduct
May 6, 2026Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782…Z-1954-2026Philips North America
May 6, 2026Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Ca…Z-1950-2026Advanced Bionics, LLC
May 6, 2026Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: A…D-0491-2026Alcon Research LLC
May 6, 2026Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neur…Z-2008-2026Medline Industries, LP
May 6, 2026Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (RE…Z-1965-2026Philips North America
May 6, 2026Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYZ-2004-2026Merit Medical Systems, Inc.
May 6, 2026Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (R…Z-1968-2026Philips North America
May 6, 2026Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads…Z-2045-2026Medline Industries, LP
May 6, 2026Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as…Z-2039-2026Medline Industries, LP
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: …Z-2035-2026Medline Industries, LP
May 6, 2026fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100…D-0503-2026Wells Pharma of Houston LLC
May 6, 2026Brand Name: Leksell Vantage Arc System REF: 1053958Z-2006-2026Elekta, Inc.
May 6, 2026fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL…D-0504-2026Wells Pharma of Houston LLC
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: …Z-2016-2026Medline Industries, LP
May 6, 202652USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking w…H-0676-2026Guangdong Zonegoing Food Co., LTD
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. …Z-2034-2026Medline Industries, LP
May 6, 202652USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinkin…H-0677-2026Guangdong Zonegoing Food Co., LTD
May 6, 2026Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic pac…H-0686-2026HEMU TRADING INC
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SP…Z-2011-2026Medline Industries, LP
May 6, 2026Heraeus, PALAMIX uno. Material Number: 66057893.Z-1997-2026Heraeus Medical GmbH (Dental Division)
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: …Z-2030-2026Medline Industries, LP
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURD…Z-2027-2026Medline Industries, LP
May 6, 2026Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.Z-1969-2026Philips North America
May 6, 2026Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styleZ-1943-2026Healthmark Industries Co., Inc.
May 6, 2026Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.Z-1993-2026DEPUY (IRELAND)
May 6, 2026Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET W…D-0509-2026Water-Jel Technologies, LLC
May 6, 2026Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula …Z-1946-2026Zimmer, Inc.
May 6, 2026Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2…Z-1956-2026Philips North America
May 6, 2026Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Ki…D-0507-2026Wells Pharma of Houston LLC
May 6, 2026Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (M…H-0680-2026LACTALIS CANADA, INC
May 6, 2026iLet Bionic Pancreas, REF: BB1001Z-1996-2026Beta Bionics, Inc.
May 6, 2026Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For pr…Z-1984-2026Immuno-Mycologics, Inc
May 6, 2026Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made …D-0501-2026Thea Pharma, Inc.
May 6, 2026Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. En…Z-1994-2026Straumann USA LLC
May 6, 2026Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refr…H-0685-2026King Juice Company, Inc.
May 6, 2026Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.Z-1989-2026DEPUY (IRELAND)
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINEC…Z-2038-2026Medline Industries, LP
May 6, 2026AIDBAGs are first aid kits of convenience composed of individually labeled devices design…Z-1947-2026North American Rescue LLC.
May 6, 2026Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYZ-2002-2026Merit Medical Systems, Inc.
May 6, 2026Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as…Z-2042-2026Medline Industries, LP
May 6, 2026Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (RE…Z-1966-2026Philips North America
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SP…Z-2012-2026Medline Industries, LP
May 6, 2026Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. …Z-1962-2026Philips North America
May 6, 2026Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…Z-1771-2026Boston Scientific Corporation
May 6, 2026BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useZ-1982-2026Becton Dickinson & Co.
May 6, 2026Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.Z-1957-2026Philips North America
May 6, 2026Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: …Z-2020-2026Medline Industries, LP
May 6, 2026Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. …Z-1963-2026Philips North America
May 6, 2026i-STAT EG7+ cartridge; List Number: 03P76-25;Z-1999-2026Abbott Point Of Care Inc.
May 6, 2026Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: …Z-2040-2026Medline Industries, LP

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