Delaware recalls

Sold nationwide. Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.

Serious·FDA·Aug 26, 2026·Siemens2 products

Sold nationwide. Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.

Moderate·FDA·Aug 26, 2026·AVID Medical

Sold nationwide. Getinge's Maquet Critical Care AB recalled nine Y Sensor modules (Model 6693662) for SERVO-U and SERVO-N ventilator systems. The modules did not complete electrical safety and functional tests during production. They were distributed to facilities in California, Georgia, Minnesota, and New York, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Maquet

Sold nationwide. Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Boston Scientific2 products

Sold nationwide. Tobii Dynavox is recalling two TD Navio speech generating devices: the TD Navio Midi (model 1000798) and the TD Navio Maxi (model 1000799). Under certain conditions, the battery mounting tabs can become damaged, letting the battery move inside the device and possibly causing an internal short circuit, localized heating, and gas venting. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Tobii Dynavox2 products

Sold nationwide. Arrowhead DE LLC is recalling certain Arrow-LOK implants used to fix bones in the lesser toes after corrective surgery. The implants did not complete a required gamma radiation dose audit, which could reduce their sterility and potentially lead to patient infection. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Arrowhead

Sold nationwide. The ARVIS Surgical Navigation System Gen 2, a computer-controlled device used by surgeons to help position orthopedic implants during knee, hip, and shoulder surgery, has a sensor issue that can cause the image displayed through the eyepiece to appear tilted. This misalignment could affect the accuracy of surgical guidance if the surgeon relies solely on the displayed image without cross-checking with other alignment methods.

Moderate·FDA·Aug 26, 2026·Kico

Sold nationwide. The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 2026·Philips2 products

Dentsply Sirona and SDI Limited are recalling about 1,444 Capsule Mixers, Model No. 5546068, with serial numbers in the 0003-1533 range. The units can release an electrical discharge when they are unplugged. The notice reports no injuries.

Moderate·FDA·Aug 26, 2026·SDI

Sold nationwide. Intersurgical is recalling two sizes of its One-Piece Guedel Airway, a device used to keep a patient's airway open. The devices could be blocked or partly blocked, and about 22,844 units are affected. They were distributed nationwide, with US distribution in CT, FL, IN, MI, OH, and VA, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Intersurgical2 products

Sold nationwide. Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.

Moderate·FDA·Aug 26, 2026·Foundation Medicine

Sold nationwide. The EndoFLIP endoscopic measuring system has a 24-hour usage limit that causes catheters to be incorrectly marked as expired. This prevents catheters from being used in clinical procedures even though they may still be suitable for use.

Moderate·FDA·Aug 26, 2026·Covidien

Sold nationwide. Spectral Instruments is recalling 75 units across two products: 40 Lago X and 35 Ami HTX. The on-screen "X-Ray On" banner can briefly be absent during the run readiness check. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Spectral Instruments2 products

Lidl US is recalling Vitasia Asian Style Wok Spice Mix after a positive test for Salmonella bacteria. The affected product is the 1.58 oz (45g) package with lot number 155846 and best-if-used-by date of June 2028. This spice mix was sold in Washington DC, Delaware, Georgia, Maryland, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, and Virginia.

Serious·FDA·Aug 26, 2026·Vitasia

Sold nationwide. Coast Citrus Distributors is recalling bulk jalapeno peppers packaged between July 1–31, 2026, due to potential Salmonella Javiana contamination. The peppers were distributed in bulk containers to wholesale distributors across the central and eastern United States, with further nationwide distribution for food processing. No retail packages or consumer illnesses have been identified.

Serious·FDA·Aug 26, 2026·Coast Tropical

Prospector Popcorn is recalling four gourmet popcorn flavors: Chocolate Mocha, Maple Walnut Ice Cream, Fudge Brownie, and Belgian Chocolate Toffee, in 1.5 oz and 3.5 oz sizes. The nutrition labels understate carbohydrate and cholesterol amounts. No illnesses or injuries have been reported.

Moderate·FDA·Aug 26, 2026·Prospector Popcorn4 products

Sold nationwide. American Regent is recalling 12 injectable and oral solution products, including nitroglycerin, cyanocobalamin (vitamin B12), aminocaproic acid, atropine, acetylcysteine, selenious acid, papaverine, niCARdipine, and the trace element products Multrys and Tralement. Some vials may contain particulate matter identified as hair, glass, and/or paraformaldehyde. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·American Regent12 products

Sold nationwide. Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.

Serious·FDA·Aug 26, 2026·Fresenius Kabi

Sold nationwide. Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Mylan

Sold nationwide. Golden State Medical Supply is recalling Carbamazepine Tablets, USP 200mg due to black specks found in some tablets. This is a manufacturing quality issue. The affected lots were distributed nationwide.

Moderate·FDA·Aug 26, 2026·Golden State Medical Supply

Sold nationwide. Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Sun Pharmaceutical

Sold nationwide. Regeneron is recalling one lot of Libtayo (cemiplimab-rwlc), an intravenous cancer treatment, because the manufacturer cannot guarantee the vials are sterile. This affects lot 8494000002, which expires July 31, 2028. About 21,353 vials are involved in the recall nationwide.

Moderate·FDA·Aug 26, 2026·Regeneron

Sold nationwide. Certain vials of PEMRYDI RTU (pemetrexed injection) have developed green to dark green discoloration. The affected lots are P400172 and PA00050A, expiring 09/30/2027. Discoloration may indicate a quality issue with the medication.

Moderate·FDA·Aug 26, 2026·Shilpa Medicare2 products

Sold nationwide. The Better Bakehouse Snack Company recalled certain lots of Donutful Chocolate Dipped Vanilla Cake Donuts because they may contain milk that is not listed on the label. People with a milk allergy or severe sensitivity could have a serious allergic reaction if they eat this product.

Serious·FDA·Aug 25, 2026·Donutful

Sold nationwide. Baxter is recalling two lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and dialysis centers because fiberglass particles have been found in the solution. The affected lots were distributed to hospitals and medical suppliers in 14 states between July 31 and August 3, 2026. No injuries have been reported so far.

Serious·FDA·Aug 25, 2026·Baxter

Sold nationwide. Baxter is recalling one lot of 70% Dextrose Injection used in hospitals and care facilities because stainless steel particles were found in the solution. If given intravenously, these particles could cause blood clots, block blood vessels, or damage organs. No patient injuries have been reported so far.

Serious·FDA·Aug 25, 2026·Baxter

Sold nationwide. Vitruvias Therapeutics is recalling one lot (504950) of Thyroid Tablets, USP 30 mg because testing found the tablets may contain higher-than-intended amounts of thyroid hormone. Taking overly potent thyroid medication can cause an overactive thyroid, leading to weight loss, rapid heartbeat, chest pain, and other serious symptoms, especially in elderly people, pregnant women, and infants.

Moderate·FDA·Aug 21, 2026·Vitruvias Therapeutics

Sold nationwide. Fromm Family Foods is recalling two wet dog food products: Turkey Pâté and Diner Classics Milo's Meatloaf Pâté, sold in 12.2 oz. and 12.5 oz. cans with a Best By date of 032029. The recall is due to potential metal contamination discovered during production. If dogs eat metal, they can choke, vomit, lose appetite, or suffer cuts and blockages in the mouth or digestive tract.

Serious·FDA·Aug 21, 2026·Fromm

Sold nationwide. CCM Hockey visors and replacement visor accessories can crack when hit during play, potentially causing cuts or impact injuries. The recalled products are FMHVR Hybrid Visors and ACCHVR Replacement Visor accessories with specific serial numbers.

Serious·CPSC·Aug 20, 2026·CCM

Sold nationwide. Workbless pressure washer models WB0301 and WB0302 lack proper electrical safety features—specifically a ground-fault circuit-interrupter (GFCI) and an adequate power cord. This creates a serious risk of electric shock or electrocution during use.

Serious·CPSC·Aug 20, 2026·Workbless