Massachusetts recalls

Sold nationwide. Happiest Baby has distributed extra-small and extra-large sizes of the SNOO Sleep Sack without FDA safety and effectiveness review. These sizes were not cleared through the required regulatory process before being sold.

Moderate·FDA·Sep 23, 2026·Happiest Baby2 products

Sold nationwide. The VERIQA RT MonteCarlo 3D v3 radiation therapy planning software includes bolus (a material placed on the skin to modify radiation dose) in dose calculations, but does not clearly display that the bolus is accounted for. This may cause treatment staff to accidentally skip the bolus during treatment, leading to radiation being delivered to the wrong tissue depth.

Moderate·FDA·Sep 23, 2026·PTW Freiburg

Sold nationwide. Straumann USA LLC is recalling the GM Helix Implant (REF 109.984) because the product label on the packaging does not match the actual dimensions of the implant inside. This mismatch could lead to use of an incorrect implant size during dental procedures. The affected lot (VZPF4) was distributed nationwide to dental providers.

Moderate·FDA·Sep 23, 2026·Straumann

Sold nationwide. The 6Fr suction catheter may not pass smoothly through certain SunMed Tracheal Tube Size 2.5 samples (Model 1-7333-25), creating a potential obstruction during use. This issue affects multiple lot numbers distributed nationwide.

Moderate·FDA·Sep 23, 2026·Well Lead

Sold nationwide. GE Healthcare is recalling six medical imaging and archive software products, with about 4,000 systems affected. Under certain conditions, historical imaging data moved from an older system can be linked to the wrong patient, so studies or images may appear in another patient's record. No injuries have been reported.

Serious·FDA·Sep 23, 2026·GE Healthcare6 products

Sold nationwide. The oxygen tubing in certain NOxBOXi Nitric Oxide Delivery Systems may leak or disconnect, which could reduce oxygen flow to the patient. This happens because the tubing or its connection can fail. The recall affects 1,547 units with specific serial numbers.

Moderate·FDA·Sep 23, 2026·Noxbox

Sold nationwide. Nuclein LLC is recalling specific units of the DASH Rapid PCR Instrument due to a software issue in versions 6.0.2, 6.0.4, 6.0.5, and 6.0.6. The affected instruments are used in clinical laboratories to detect infectious diseases through rapid PCR testing. The software problem may impact the accuracy or reliability of test results.

Moderate·FDA·Sep 23, 2026·Nuclein

Sold nationwide. ICU Medical is recalling eight IV administration sets with drip chambers. The drip chambers may have black specks, which may come from discolored plastic left behind during manufacturing. The company has not ruled out discoloration or particles in the fluid path. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·ICU Medical8 products

Sold nationwide. Abiomed is recalling three groups of Impella controllers, about 10,750 units in total, that are used with heart pump systems. A component in the purge pressure sensor assembly, the purge flag, can fail, which may stop the controller from correctly recognizing the purge cassette. No injuries have been reported.

Serious·FDA·Sep 23, 2026·Abiomed3 products

Sold nationwide. Bayer Medical Care has recalled MEDRAD Stellant FLEX Syringe Kits (catalog number FLEXS-150-QFT) used with the Stellant FLEX CT Injection System because some devices may not have been properly sterilized during manufacturing. The recall affects approximately 27,800 kits across the United States.

Moderate·FDA·Sep 23, 2026·Bayer

Sold nationwide. Maquet is recalling three Percutaneous Insertion Kit products because the packaging may not consistently maintain the sterile barrier. No injuries have been reported. About 271,000 units were distributed in the US and many other countries.

Moderate·FDA·Sep 23, 2026·Maquet3 products

Sold nationwide. GE's Carescape Central Station patient monitoring system may take up to 3 minutes to resume monitoring after a restart. During this gap, clinically important changes in a patient's condition might not be detected right away.

Moderate·FDA·Sep 23, 2026·GE

Sold nationwide. Philips is recalling two patient information system products because a software malfunction can cause the system to freeze and stop responding. The recall includes 7,671 affected units across the two products, which were distributed in the US and internationally. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·Philips2 products

Sold nationwide. Medline's Open Heart Convenience Kit (DYNJ43008N) contains a coronary cannula with a potential sterile barrier breach. If a compromised pouch seal isn't caught before use, the non-sterile device could cause infection or serious complications including blood cell breakdown, blood clots, or organ damage.

Serious·FDA·Sep 23, 2026·Medline

Sold nationwide. Nova Biomedical is recalling five StatStrip glucose meter models, about 44,400 units in total. A software timing issue can cause a meter to keep the previous patient's or control solution's barcode on screen, so a glucose result may be recorded under the wrong patient. The glucose measurements themselves are not affected, and no injuries have been reported.

Serious·FDA·Sep 23, 2026·Nova Biomedical5 products

Sold nationwide. Medline is recalling seven groups of convenience kits because certain lots of sterile applicators may contain fungus (Aspergillus penicillioides). Skin preparation products contaminated with this fungus can cause serious infections, including sepsis, and death. The kits were distributed nationwide, and the FDA has classified this as a Class I recall, its most serious category.

Serious·FDA·Sep 23, 2026·Medline7 products

Sold nationwide. Halyard IV START KIT convenience kits (Lot 1658437) contain applicators contaminated with Aspergillus penicillioides, a fungus. The contamination was found in BD ChloraPrep Clear and FREPP Clear applicators included in the kits. This is a Class I recall affecting 288 units distributed in Nebraska.

Serious·FDA·Sep 23, 2026·AVID MedicalExpanded Sep 30

Sold nationwide. BD Switzerland has recalled multiple models of Alaris Pump Infusion Sets due to discrepancies in performance data attributes. These discrepancies may cause the infusion pump to operate inappropriately. No injuries have been reported.

Serious·FDA·Sep 23, 2026·BD

Sold nationwide. Bard is recalling 2 product lines of short-term straight dialysis catheters, with about 172,500 units affected. The recall is downstream of a related Class I recall, RES 98777, and the filing does not describe the specific hazard. No injuries have been reported.

Serious·FDA·Sep 23, 2026·Bard2 products

Tiffany Food Corp's Hexing Haw Balls candy contains Ponceau 4R, a food dye that is not approved for use in the United States. The affected product is sold in 200g clear plastic bags with a best-before date of 10/01/2026.

FDA·Sep 23, 2026·Tiffany Food

Taylor Farms is recalling 25 fresh products because they may be contaminated with Salmonella. The products include pico de gallo, salsas, guacamole, dips, salads, a burrito and a sandwich, sold under the Taylor Farms name and also under Walmart, ADUSA Distribution and BH Bold names. Affected units were sent to several states, including Texas, Illinois, Kentucky, Tennessee, Florida and Rhode Island. No illnesses have been reported.

Serious·FDA·Sep 23, 2026·Taylor Farms25 products

Sold nationwide. Foods Alive organic moringa leaf powder in 8oz pouches may be contaminated with Salmonella. About 1,691 pouches were distributed nationwide and online. No illnesses have been reported so far.

Serious·FDA·Sep 23, 2026·Foods Alive

Sold nationwide. Vitruvias Therapeutics is recalling Thyroid Tablets, USP 1/2 Grain (30 mg) because the tablets are superpotent—meaning they contain higher-than-intended levels of active ingredients. This lot was distributed nationwide. The affected lot number is 504950, expiring 09/30/2026.

Serious·FDA·Sep 23, 2026·Vitruvias Therapeutics

Sold nationwide. Pfizer has recalled one lot of Dopamine HCl injection (40 mg/mL) distributed nationwide due to a lack of assurance of sterility. The affected lot is NL5230, with an expiration date of October 2027. This is a precautionary measure to ensure patient safety.

Moderate·FDA·Sep 23, 2026·Pfizer

Sold nationwide. Inventia Healthcare Limited's chlorthalidone 25 mg tablets (batch RISA24002, expiring 04/2027) failed to meet dissolution specifications, meaning the tablets may not break down properly in the body. This could affect how well the medication works. About 13,567 bottles were distributed nationwide.

Moderate·FDA·Sep 23, 2026·Inventia Healthcare

Sold nationwide. Taro Pharmaceuticals is recalling one lot of Lidocaine Ointment USP 5% because testing found the active ingredient strength was outside acceptable limits. The affected lot was identified during long-term stability testing. No injuries have been reported.

Moderate·FDA·Sep 23, 2026·Sun Pharmaceutical

Sold nationwide. Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 2.5 mg per 5 mL because they failed stability testing, meaning the medication may not maintain its strength or safety over time. The affected lots were distributed nationwide.

Moderate·FDA·Sep 23, 2026·Safecor Health6 products

Sold nationwide. Sun Pharmaceutical is recalling specific lots of Nystatin Cream, USP (15 g tubes) because the medication failed stability testing. This means the cream may not maintain its expected strength or safety over time. The affected lots are AD49605 and AD49606, with expiration dates of 05/31/2027.

Moderate·FDA·Sep 23, 2026·Sun Pharmaceutical

Sold nationwide. Heinz Real - Vraie Mayonnaise 12.5ml single-serving packets contain undeclared ingredients, including mustard. This poses a risk to people with mustard allergies. The affected packets have best-by dates of March 27 or 28, 2027, and were distributed in Canada.

Moderate·FDA·Sep 23, 2026·Heinz

Sold nationwide. Star Meat Delivery Inc. produced approximately 167,639 pounds of raw pork, beef, and goat products without federal inspection and labeled them with a false USDA inspection mark (establishment number EST. 1363). The products were distributed in bulk under the A&D Foods label to retailers and restaurants nationwide. Food produced without inspection may contain harmful bacteria, undeclared allergens, or other contaminants.

Serious·USDA·Sep 22, 2026·A&D Foods