Recalls & alerts

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

• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number:…

  Medline Industries is recalling its Convenience Kits, including blood draw, phlebotomy, and blood culture kits. The kits' sterile packaging may be compromised by wrinkles in the paper lidding, exposing patients and users to microbial contamination. Consumers should consult the FDA recall notice for instructions.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN…

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, with multiple catalog numbers affected. The wipes may be contaminated with a lubricant, causing localized skin irritation, erythema, or mild inflammation in patients. Consumers should check the recall notice for affected catalog numbers and follow the manufacturer's instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A

  Medline Industries recalled its Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, sold as PAIN PRE OP KIT DYKS1476A. The applicator packaging may have an open or incomplete seal, exposing patients to risk of skin, soft tissue, or systemic infection. Consumers should stop using the affected kits and contact Medline for instructions on returning the product.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C

  Medline Industries is recalling three Convenience Kits: ORTHO ASPIRATION KIT DYKM1636A, SHOULD BLOCK KIT DYKM1881A, and TRIMA KIT DYNDB3077C. The kits contain applicators whose packaging may have wrinkles that break the sterile seal, exposing patients and users to microbial contamination and possible infection. Consumers should stop using the recalled kits and contact Medline Industries for instructions on returning or replacing them.

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• openFDA · September 9, 2026Moderate risk

  AVID Medical, Inc. : 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6)…

  AVID Medical is recalling numerous surgical kits containing Medicom Ritmed Neurological Sponges, non-sterile models 55992C to 55998C. The sponges may have unexpected variability in endotoxin levels, posing a risk to patients during surgical procedures. Consumers should stop using affected kits, check the recall notice for specific lots, and contact AVID Medical for instructions.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays, specifically the KIT, LUNG TX CIRCULATOR with catalog number OVC3507231. The wipes may be contaminated with a manufacturing lubricant, which can cause localized skin irritation, redness, or mild inflammation in patients. Consumers should stop using the affected wipes and contact Cardinal Health for further instructions.

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• openFDA · September 9, 2026Moderate risk

  Boston Scientific Corporation : LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)

  Boston Scientific is recalling its LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System server software, model 7246, all versions. The software may delay AF Burden Alert notifications, which could delay clinical evaluation or treatment for patients with atrial arrhythmias. Consumers should contact their healthcare provider or Boston Scientific for instructions on how to proceed.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F

  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators are affected. The hazard is an open or incomplete seal on the applicator packaging, which may lead to infection in patients using the kits. Consumers should stop using the affected kits and contact Medline for instructions.

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• openFDA · September 9, 2026Moderate risk

  Boston Scientific Corporation : LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)

  Boston Scientific's LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System with server software model 7248 is affected. The software may delay AF Burden Alert notifications, which could delay clinical evaluation or treatment for patients with atrial arrhythmias. Consumers should contact their healthcare provider to discuss the recall and any needed follow-up.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Philips North America Llc : Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  B Braun Medical Inc : Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC ,…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Philips North America Llc : Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4)…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2)…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number:…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST ,…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0,…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4)…

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Medos International Sarl : Velys Enabling Tech Robotic-Assist Station REF: 451611001

  Summary being prepared.

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• openFDA · September 9, 2026Moderate risk

  Philips North America Llc : Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

  Summary being prepared.

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