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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

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, 20263 products

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

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, 20262 products

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

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

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

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, 20266 products

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

Nipro Renal Solutions USA is recalling specific lots of Citric Complete Dry Citric Acid Concentrate used in hemodialysis because they contain higher-than-safe levels of endotoxin, a bacterial substance. The affected product was distributed nationwide and internationally.

Moderate·FDA·Sep 16, 20264 products

Bard is recalling six Foley and intermittent catheter tray products because the pericare wipes packed with them may have contamination on their surface. The recall followed customer complaints, and no injuries have been reported. The trays were distributed across the United States and in several other countries.

Moderate·FDA·Sep 16, 20266 products

Atrium Medical is recalling three Getinge PVC thoracic catheter products, covering 11 model sizes, from a single lot. Testing found bacterial endotoxin levels above the allowed limit. No injuries have been reported.

Moderate·FDA·Sep 16, 2026·Atrium Medical3 products

Lutronic's DermaV laser system may produce sparks and loud noise when used at higher energy levels (fluences) at the 1064 nm wavelength with current cooling settings. This spark hazard could result in patient burns during treatment.

Moderate·FDA·Sep 16, 2026

Halyard IV Start Kit Non-Sterile (REF: KRIV26-02) convenience kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkles in the paper lidding that may breach the seal. This compromises sterility assurance of the applicators. 98 kits in lot 1658438 (expiration 7/31/2026) were distributed nationally.

Moderate·FDA·Sep 16, 2026

OurPharma LLC's fentanyl citrate 1,000 mcg injection solution has conflicting expiration dates printed on the IV bag and product labeling. The bag shows expiry dates of 07/31/2026 or 11/30/2026, while the product itself is labeled as expiring 12/09/2026. This discrepancy could lead to confusion about when the medication is safe to use.

Moderate·FDA·Sep 16, 2026·OurPharma

Ajanta Pharma USA Inc. is recalling fluphenazine hydrochloride 1mg tablets (NDC 27241-255-01) because stability testing at 18 months found organic impurity levels slightly above specification limits. The tablets contained 1.1% of Impurity-A, exceeding the 1.0% specification. No injuries have been reported.

Moderate·FDA·Sep 16, 2026

ImprimisRx NJ LLC is recalling specific lots of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution used in medical offices because the medication contains lower-than-intended active ingredients. The affected lots may not work as intended for their intended use.

Moderate·FDA·Sep 16, 2026·ImprimisRx

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

Moderate·FDA·Sep 9, 202612 products

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

Moderate·FDA·Sep 9, 20263 products

Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

Moderate·FDA·Sep 9, 2026

A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.

Moderate·FDA·Sep 9, 2026·Medos

Fresenius Medical Care is recalling four 5008X blood tubing set models because the connection between the Arterial Alpha Clip and the main line or pump segment may leak blood during treatment. A leak could cause blood loss and low blood volume. No injuries have been reported.

Moderate·FDA·Sep 9, 20264 products

Boston Scientific is recalling server software that supports its LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors. The recall covers three products, one for each region: US, EU, and ANZ. The software can delay notifications of AF Burden Alerts, which are alerts about atrial fibrillation, and a delayed alert may delay clinical review or treatment. No injuries have been reported.

Moderate·FDA·Sep 9, 20263 products

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

Moderate·FDA·Sep 9, 202613 products

Baxter is recalling two Novum IQ syringe pump models, totaling about 14,605 units. During a Volume/Time (VOT) multi-syringe infusion, a software issue may occur if a syringe runs empty and is replaced while the Volume To Be Infused (VTBI) is still remaining. No injuries have been reported.

Moderate·FDA·Sep 9, 20262 products

Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Moderate·FDA·Sep 9, 2026·Johnson & Johnson Surgical Vision

Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

Moderate·FDA·Sep 9, 202616 products

Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.

Moderate·FDA·Sep 9, 2026

Medicom is recalling specific lots of Ritmed Neurological Sponges (non-sterile models 55992C to 55998C) because their endotoxin levels may vary unexpectedly. AVID Medical is recalling three groups of Halyard medical convenience kits that contain these sponges, about 28,800 kits in total. No injuries have been reported.

Moderate·FDA·Sep 9, 20263 products

Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

Moderate·FDA·Sep 9, 20264 products