Massachusetts recalls

Asteria Health estradiol 15 mg pellets may contain metal particulate matter, a foreign substance that could pose a health risk. The FDA has identified four affected lot numbers distributed nationwide. No injuries have been reported to date.

Asteria Health estradiol pellets (12.5 mg) may contain metal particulate matter. The affected lots were distributed nationwide. No injuries have been reported to date.

Asteria Health is recalling estradiol hormone pellets (10 mg) because they may contain metal particles. The affected pellets were distributed nationwide. No injuries have been reported so far.

Presence of Foreign substance - potential presence of metal particulate matter

Unichem Pharmaceuticals distributed 60,000 tablets of Doxazosin 4 mg with incorrect imprinting on the tablets themselves. This labeling error could cause confusion about the medication's identity and strength. The affected lot is GDSH25006, which expires in August 2027.

Pro Numb Tattoo Numbing Spray (4% Lidocaine) in lot J15 was distributed nationwide but did not meet FDA manufacturing standards. The spray may not be safe or effective as a result.

Pro Numb Tattoo Numbing Spray (5% lidocaine) is being recalled due to manufacturing quality control issues. The FDA found that the product was not made under proper conditions. Certain lot numbers (J01–J14 and J55–J69) distributed nationwide may be affected.

Hydromassage rotary jets in Watkins Highlife Collection spas can create strong suction that may entangle a user's hair and pull their head underwater. One incident of hair entanglement has been reported. The recall affects 2023–2025 models including Grandee, Envoy, Vanguard, Aria, Prodigy, Sovereign, Jetsetter, and Jetsetter LX spas.

Beloems model BL-BR201 portable bed rails can trap users between the rail and mattress, creating a risk of suffocation. The rails also fail safety standards for stability and secure attachment, and have incorrectly sized pins that can cause cuts.

CheerKid-branded baby bath seats (Model BH-222) can tip over during use because they are unstable, creating a serious risk of drowning. The seats do not meet safety standards for infant bath seats. About 590 units were sold on Amazon starting in September 2025.

Fortemotus Direct adult portable bed rails (model USFTMTJAS008) can trap users between the rail and mattress, creating a serious risk of asphyxiation and death. The rails also fail safety standards for stability and retention, and have incorrectly sized pins that can cause cuts.

SOOWERY 6-drawer dressers can tip over and trap children if not anchored to the wall, creating a serious injury or death risk. About 166 dressers were sold online through Amazon from December 2025 to January 2026. The dressers do not meet federal safety standards for furniture stability.

LShome brand smoke detectors sold on Amazon may fail to sound an alarm during a fire if their internal sensor settings are incorrect. This creates a serious risk that you won't be warned in time to escape a fire.

The mounting bolt on ETAC Molift 4-point sling bars (models 1430116, 1430117, 1430115) can break during assembly or use due to material deformation at the joint. This can cause the lifting bar to lose proper function, affecting the safety and reliability of the mobile hoist. About 25 units have been distributed worldwide.

The mounting bolt on Molift 2-point sling bars (models 1530101 and 1530102) can break during assembly or use due to material deformation. This can limit the joint's movement and prevent the hoist from working properly. No injuries have been reported.

The bolt that connects the lifting bar to the arm on certain Molift Mover 300 hoists can break due to material deformation in the joint. This can cause the lifting mechanism to become immobile and stop working properly, creating a safety risk during patient transfers.

The mounting bolt that holds the lifting bar on certain Molift Mover 205 patient lifts can break during use. This happens because materials in the joint deform over time, which can cause the bolt to fail and limit how the lift moves. A bolt broke during testing, prompting this recall.

Fujirebio is recalling quality control materials used in Alzheimer's disease testing labs. The controls may give falsely high or indeterminate results, causing patients to be incorrectly classified as having amyloid pathology or to receive unnecessary additional testing. This affects Model 81559, Lot T8B6116U, distributed in 13 U.S. states.

Fujirebio Diagnostics is recalling calibrator kits (model 235454, specific lot numbers) used in a blood test for Alzheimer's disease risk. The calibrators may cause inaccurate results, falsely flagging patients as positive or indeterminate for amyloid pathology when they should not be, or missing cases that should be detected.

Fujirebio Diagnostics is recalling Lumipulse G β-Amyloid 1-42 Plasma test cartridges (Model 235447, certain lot numbers) because they may produce falsely high or falsely indeterminate results. This could incorrectly classify patients as having Alzheimer's disease pathology or unnecessarily recommend further testing. Healthcare providers should stop using affected cartridges immediately.

Fujirebio Diagnostics is recalling Lumipulse pTau 217 Plasma Controls (Model 81558) used in laboratory testing for Alzheimer's disease markers. The controls may produce falsely elevated results, leading labs to incorrectly classify patients as having Alzheimer's disease or requiring additional testing.

Fujirebio Diagnostics' Lumipulse G pTau 217 Plasma Calibrators (Model 81557) may produce inaccurate test results, causing patients to be incorrectly classified as having Alzheimer's-related amyloid pathology or flagged for unnecessary additional testing. The calibration issue leads to falsely elevated results that do not match established imaging and CSF tests.

Fujirebio's Lumipulse G pTau 217 Plasma test cartridges (Model 81550) may produce inaccurate results, incorrectly classifying patients as having Alzheimer's-related amyloid pathology or flagging them for unnecessary further testing. The cartridges show higher rates of false-positive and false-indeterminate results compared to FDA-approved reference tests. Affected lot numbers are D4C6028U, D4C6029U, D4C6051U, and D4C6052U.

Fujirebio's Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test may produce inaccurate results that falsely suggest Alzheimer's disease or incorrectly flag patients for additional testing. The test can show higher-than-actual ratios, leading to wrong patient classifications compared to confirmed imaging or cerebrospinal fluid tests.

Maquet Cardiopulmonary identified a durability problem with the connecting cable on its Venous Bubble Sensor (Model 701055720). Excessive bending of the cable can damage the sensor or loosen the connection, causing error messages on the connected medical device—either temporarily when the cable moves or permanently if the connection fails.

FUJIFILM Healthcare Americas has recalled certain FDR Visionary Suite X-ray systems (Model CH-200) because internal electrical contacts can become welded together. This may allow power to continue flowing to the system even after it is turned off, which could cause the circuit to overheat, damage nearby parts, and create smoke.

Wilson-Cook Medical is recalling certain nasal jejunal feeding tubes (model NJFT-10) because some units were shipped without the nasal transfer tube component, making them incomplete and unusable. The recall affects 60 units distributed in Australia.

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0725) used during endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose performance during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (Model KD-V411M-3025) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or stop working correctly during use.

Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (model KD-V411M-3020) used in endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their ability to perform as intended.