Recalls & alerts

1084 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · October 14, 2026Moderate risk

  Intellijoint Surgical, Inc. : Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF:…

  Intellijoint Surgical is recalling its Intellijoint Navigation System Workstation G2, HIP Cart System, and HIP Portable System (REFs 000-0241, 000-0250, 000-0249). The workstation may contain a recalled 15-inch MacBook Pro battery that can overheat, posing a fire hazard to users. Consumers should stop using the affected systems and contact Intellijoint Surgical for replacement or repair.

  devices
• openFDA · October 14, 2026Moderate risk

  QUANTUM OPS Inc : Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker);…

  Quantum Ops Inc is recalling its ADAPTABLE Beach Chair surgical patient positioner, models 804-33-300 and 3105-400-030. A weak weld in the head positioning system can fail, posing injury risk to patients during surgery. Users should stop using the affected positioners and contact Quantum Ops for return or correction.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;

  AVID Medical, Inc. is recalling its Laparoscopic Prostatectomy kit, model NIHB0036-07. The kit may be contaminated with manufacturing lubricant, posing a risk to patients undergoing the procedure. Consumers should follow the recall instructions from AVID Medical.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : BeneView Series. Operator's Manuals: T5 / T8

  Mindray DS USA is recalling operator's manuals for its BeneView Series T5 and T8 monitors. The manuals have insufficient or unclear descriptions of certain physiological alarm functions, affecting users of these monitors worldwide. Consumers should contact Mindray DS USA to receive corrected manuals.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12

  Mindray DS USA is recalling the operator's manuals for its cPM 8 and cPM 12 patient monitors. The manuals have unclear or insufficient descriptions of certain physiological alarm functions, which could lead to incorrect use and put patients and healthcare providers at risk. Users should stop using the affected manuals and obtain the corrected version from Mindray.

  devices
• openFDA · October 14, 2026Moderate risk

  Beckman Coulter Inc. : DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520

  The affected products are Beckman Coulter DxC 500 AU Clinical Chemistry Analyzers, part numbers C63519 and C63520. A software issue can silently revert test units to default settings, causing falsely elevated plasma test results for patients. Users should contact Beckman Coulter for guidance on correcting the configuration.

  devices
• openFDA · October 14, 2026Moderate risk

  Canon Medical System, USA, INC. : Alphenix INFX-8000C/B5

  Canon Medical System USA is recalling its Alphenix INFX-8000C/B5 imaging system. Loose bolts in the longitudinal movement mechanism can shift the tabletop, causing misalignment and motion errors for patients and operators. Users should stop using the affected system and contact Canon Medical for inspection and repair.

  devices
• openFDA · October 14, 2026Moderate risk

  GRI Medical & Electronic Technology Co., Ltd. : HALYARD Laparoscopy Comprehensive Pack II REF: 49332

  The HALYARD Laparoscopy Comprehensive Pack II REF 49332, made by GRI Medical & Electronic Technology Co., Ltd., is affected. The packs are labeled "latex free" but contain a latex urethral catheter, exposing patients with latex allergies to a hazard. The firm initiated a voluntary recall of the affected packs.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

  AVID Medical, Inc. is recalling its Endovascular Pack, model VAPX014-04. The product may be contaminated with a manufacturing lubricant, posing a risk to patients and healthcare workers in Arizona, California, Florida, Maryland, Nebraska, and Texas. Consumers should stop using the affected kits and follow the firm's recall instructions for return or replacement.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80

  Mindray DS USA is recalling operator's manuals for BeneVision Series Telemetry Monitors TM70 and TM80. The manuals have unclear descriptions of certain physiological alarm functions, which could lead to incorrect monitoring for patients. Consumers should review the corrected manual or contact Mindray for updated instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;

  AVID Medical, Inc. is recalling its DAVINCI LAP/GYN kit, model WRNM037-16. The product may be contaminated with manufacturing lubricant, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the affected kit and contact AVID Medical for return instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC : SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

  The recall affects SEDIPLAST tubes, models S-100 and S-1000, from Polymedco, Inc. and Polymedco Cancer Diagnostic Products, LLC. During use, increased resistance when inserting the pipette can cause the cap to detach and release blood, exposing the operator and work area to a biological hazard. Consumers should stop using the affected tubes and contact the company for further instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Beckman Coulter Inc. : DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module,…

  Beckman Coulter is recalling its DxC 500i Clinical Analyzer Modules, including part numbers C63522, C63521, and C13252. A software issue can revert configured test units to default without warning, causing falsely elevated results for patients whose plasma samples are tested. Users should follow the firm's recall instructions and contact Beckman Coulter for correction.

  devices
• openFDA · October 14, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit…

  Cardinal Health 200, LLC is recalling Presource Packs containing Medtronic Microstream Components, including specific intubation and intubating bag kit catalog numbers. The hazard is difficulty disconnecting the adapter from the patient's endotracheal tube, which can delay treatment, cause unintended extubation, and lead to respiratory failure, hypoxia, aspiration, or low oxygen saturation. Consumers should follow the firm's voluntary recall instructions for the affected kits.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).

  Mindray DS USA, Inc. is recalling operator's manuals for its Panorama and Telemetry Monitoring System, including TMS-6016, Panorama Telepack-608, and TMS60 (TD60). The manuals have insufficient or unclear descriptions of selected physiological alarm functions, which could affect patients and healthcare users relying on the system. Consumers should contact Mindray DS USA, Inc. for corrected manual instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;

  The affected product is the AVID Medical MAJOR PACK, model NIHB0018-11. The device may be contaminated with a manufacturing lubricant, posing a risk to patients and users in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the product and follow the firm's recall instructions for return or disposal.

  devices
• openFDA · October 14, 2026Low risk

  Medical Action Industries, Inc. 306 : Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software…

  Medical Action Industries is recalling its Urinary Clean Catch Kit, model 76769, lot 333606. The kit’s label shows an incorrect expiration date of March 31, 2027, instead of February 28, 2027, which may lead to use after the true expiry. Consumers who have lot 333606 should stop using the kit and contact Medical Action Industries for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;

  AVID Medical, Inc. is recalling its GYN LAPAROSCOPY/LAPAROTOMY kits, models WRNM002-15 and FBCH108-03. The kits may be contaminated with a manufacturing lubricant, posing a risk to patients. Consumers should stop using the affected kits and contact AVID Medical for instructions.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.

  Mindray DS USA is recalling its BeneVision N1 and N-Series patient monitors, models N12, N15, N17, N19, and N22. The operator's manuals lack clear descriptions of certain physiological alarm functions, which could lead users to miss or misinterpret alarms, affecting patient safety. Users should review the corrected manual provided by the firm or contact Mindray for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;

  AVID Medical, Inc. is recalling its ABD HYSTERECTOMY kit, model NAMC438-07. The kit may be contaminated with a lubricant used during manufacturing, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the kit and contact AVID Medical for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;

  AVID Medical, Inc. is recalling its GYN LAPAROSCOPY PACK, model NAMC436-12. The kit may be contaminated with a lubricant from manufacturing, posing a risk to patients during gynecologic laparoscopy. Consumers should stop using the affected kit and contact AVID Medical for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Medline Industries, LP : Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support…

  Medline Industries is recalling its Bariatric Basic Steel Burgundy rollator, model MDS86800XWS. The front wheel assembly may detach, causing falls and severe injuries such as head trauma or bone fractures for users. Consumers must stop using the rollator if the front wheels become loose or detach.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Biological Steam Test Pack Model/Catalog Number: S3069

  Steris Corporation is recalling its VERIFY Biological Steam Test Pack, model S3069. The spore population may be too low, causing a false pass for steam sterilization and exposing patients to improperly sterilized equipment. Consumers should stop using the affected test packs and contact Steris for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;

  AVID Medical, Inc. is recalling its DAVINCI TRUCUSTOM BUNDLE kits, model numbers SAMM064-27 and SAMM064-28. The kits may be contaminated with a lubricant from manufacturing, posing a risk to patients or users. Consumers should stop using the affected kits and contact AVID Medical for return or replacement.

  devices
• openFDA · October 14, 2026Low risk

  Mindray DS USA, Inc. : ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A

  Mindray DS USA is recalling its ePM Series Patient Monitors, including models ePM 10M, 12M, 12MA, 15M, and 10A. The operator's manuals have insufficient or unclear descriptions of selected physiological alarm functions, which could affect patient safety. Consumers should contact Mindray DS USA to obtain corrected operator manuals.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;

  AVID Medical, Inc. is recalling its UROLOGY MAJOR kit, model WRNM058-10. The kit may be contaminated with a lubricant used during manufacturing, posing a risk to patients in AZ, CA, FL, MD, NE, and TX. Consumers should stop using the kit and contact AVID Medical for return and replacement instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control,…

  The affected product is the Steris Corporation HexaVue Focus Integration System, software version 2.0.18. A software issue may cause incorrect patient information on manually printed images, leading to documentation errors for patients and healthcare providers. Consumers should contact Steris Corporation for recall instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;

  AVID Medical, Inc. is recalling its Craniotomy Pack, model WRNM035-20. The kit may be contaminated with manufacturing lubricant, posing a risk to patients undergoing surgery. Consumers should stop using the affected kit and contact AVID Medical for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Onkos Surgical, Inc. : Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

  The recall affects Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M. The implants were inadvertently mixed up and distributed to incorrect customers, exposing patients in North Carolina and California to potential surgical mismatch. Consumers should contact their healthcare provider to determine if their implant is affected and seek guidance.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;

  AVID Medical, Inc. is recalling its Adult Heart Tray Shands Jacks, model SHND419-08. The product may be contaminated with a manufacturing lubricant, posing a risk to patients during heart procedures. Consumers should stop using the affected kit and contact AVID Medical for return instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007

  Steris Corporation is recalling its VERIFY Biological/Integrator Challenge Pack, model LCB007. The spore population may fall below specification, causing false negative results in steam sterilization monitoring, exposing users to potentially unsterile instruments. Consumers should stop using affected packs and contact Steris for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  AVID Medical, Inc. : ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

  AVID Medical, Inc. is recalling its Robotic Prostatectomy Pack, model NAMC423-11. The pack may be contaminated with a lubricant used during manufacturing, posing a risk to patients. Consumers should stop using the affected pack and contact AVID Medical.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060

  Steris Corporation's VERIFY Dual Species Self-Contained Biological Indicator Model S3060 is affected. The spore population may fall below specification, causing false sterilization results for users monitoring steam cycles. Consumers should follow the recall instructions provided by Steris Corporation.

  devices
• openFDA · October 14, 2026Moderate risk

  Limitless Cryo Spa LLC : Glypto Device, Glypto Cryo Machine;

  Limitless Cryo Spa LLC is recalling its Glypto Device and Glypto Cryo Machine. The devices lack required FDA 510(k) clearance, posing a safety risk to users nationwide. Consumers should stop using the devices and contact Limitless Cryo Spa LLC for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061

  Steris Corporation is recalling its VERIFY Dual Species Self-Contained Biological Indicator, model S3061. The spore population may fall below specification, causing a false pass in steam sterilization monitoring, affecting users worldwide. Consumers should stop using affected units and contact Steris Corporation for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006

  The affected product is the Steris Corporation VERIFY Biological/Integrator Challenge Pack, model LCB006. The spore population may fall below specification, causing a false negative that could expose users of steam sterilization cycles to ineffective sterilization. The recall is voluntary and initiated by the firm.

  devices
• openFDA · October 14, 2026Moderate risk

  Safeguard US Operating LLC : Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive…

  Safeguard US Operating LLC is recalling its Battle Bandage and many stocked IFAK and trauma kits containing it. The compression bandage may be degraded, allowing foreign material into wounds and causing infection or other harm to users. Consumers should stop using affected products and follow the FDA recall notice for return instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Nihon Kohden America LLC : Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05,…

  Nihon Kohden CNS-6200 Series Central Nurse Station, model CN-6201, with software versions 01-03 through 02-40, is affected. A cybersecurity vulnerability could disrupt centralized monitoring and alarm visualization, exposing medical professionals and patients. Users should contact Nihon Kohden America to address the issue.

  devices
• openFDA · October 14, 2026Moderate risk

  Onkos Surgical, Inc. : Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

  The recall affects Onkos Surgical My3D Personalized Pelvic Implant, Porous, Left, REF PV-ACREC-04M. The hazard is that implants were mixed up and sent to wrong customers, so patients may receive a device meant for someone else. Consumers should contact Onkos Surgical or their healthcare provider to verify and return the implant.

  devices
• openFDA · October 14, 2026Moderate risk

  Medline Industries, LP : Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support…

  Medline Industries is recalling its Bariatric Basic Steel Blue Rollator, a four-legged metal walker. The front fork stem bolt/wheel assembly may disconnect, causing the front wheels to loosen or detach and leading to falls with head trauma, fractures, or other critical injuries for users. Consumers should stop using the rollator and contact Medline Industries for further instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  PHILIPS MEDICAL SYSTEMS : Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside…

  Philips Medical Systems Spectral CT and Spectral CT 7500 RT with certain software versions are affected. Software issues can cause image artifacts, wrong slice thickness, or unintended system motion, affecting patients and operators. Users should contact Philips Medical Systems for instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Medtronic MiniMed, Inc. : Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an…

  The recall affects Medtronic MiniMed Flex Insulin Pumps, models MMT-8062 and MMT-8072. Some pumps were released without passing all functional tests, which may cause issues such as inoperability, disconnections, or inaccurate insulin delivery for users. Consumers should contact Medtronic MiniMed for recall instructions.

  devices
• openFDA · October 14, 2026Moderate risk

  Steris Corporation : VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

  Steris Corporation's VERIFY Biological Steam Test Pack Model S3065 is affected. The spore population may fall below specification, causing a false pass in steam sterilization monitoring, exposing healthcare users to ineffective sterilization. The recall is voluntary and firm initiated, but no consumer action is specified in the notice.

  devices
• openFDA · October 14, 2026Moderate risk

  Stryker Sustainability Solutions : BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

  Stryker Sustainability Solutions is recalling its BARD EP XT Decapolar Steerable Diagnostic EP Catheter, REF 201007. A breached sterile barrier may expose patients to particulate embolization, infection, thrombus, or granuloma formation. Users should stop using the affected catheters and return them to Stryker.

  devices
• openFDA · October 14, 2026Moderate risk

  Apothecary Pharma LLC : Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.

  Apothecary Pharma LLC is recalling Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vials, prescription only. The vials lack assurance of sterility, posing a risk of infection to patients who receive the injection nationwide. Consumers should stop using the recalled vials and contact their healthcare provider or pharmacy for instructions.

  drugs
• openFDA · October 14, 2026Moderate risk

  K.C. Pharmaceuticals, Inc. : Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz…

  K.C. Pharmaceuticals, Inc. is recalling sterile eye drops redness relief sold under brands including Leader, Discount Drug Mart, Equaline, Colirio Ojo de Aguila, Clear Eyes, Equate, Walgreens, and Xpect. The products lack assurance of sterility, posing a risk of infection to consumers who use them. Consumers should stop using the recalled eye drops and return them to the place of purchase or discard them.

  drugs
• openFDA · October 14, 2026Moderate risk

  Carolina Infusion, LLC : SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina…

  Carolina Infusion, LLC is recalling Sermorelin Acetate 1 mg/mL injectable, packaged in single-use dosage syringes and distributed nationwide. The product lacks assurance of sterility, exposing patients who receive the injectable to a potential risk of infection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for guidance.

  drugs
• openFDA · October 14, 2026Moderate risk

  Carolina Infusion, LLC : SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

  Carolina Infusion LLC is recalling semaglutide 3 mg/mL injectable syringes, 8 x 0.1 mL, distributed nationwide. The product lacks assurance of sterility, exposing patients to risk of infection. Consumers should stop using the recalled syringes and contact Carolina Infusion LLC for instructions.

  drugs
• openFDA · October 14, 2026Moderate risk

  Carolina Infusion, LLC : SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…

  Carolina Infusion, LLC is recalling its Semaglutide/Cyanocobalamin 3/2 mg/mL injectable, packaged in single-use dosage syringes. The product lacks assurance of sterility, exposing patients to potential infection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy.

  drugs
• openFDA · October 14, 2026Moderate risk

  K.C. Pharmaceuticals, Inc. : Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC…

  K.C. Pharmaceuticals, Inc. is recalling sterile eye drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%) sold under brands Equaline, Good Sense, H.E.B, QC-Quality Choice, and TopCare. The products lack assurance of sterility, posing a risk of infection to consumers who use them. Consumers should stop using the recalled eye drops and return them to the place of purchase.

  drugs

Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.