Recalls & alerts

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

• openFDA · September 23, 2026Moderate risk

  Happiest Baby, Inc : Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512…

  Happiest Baby, Inc. SNOO Sleep Sack infant sleep sacks in Extra Small and Extra Large sizes are affected. These products have not been reviewed for safety and effectiveness by the FDA, exposing infants to potential unverified risks. Consumers must stop using the affected sleep sacks because they have not been reviewed by the FDA.

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• openFDA · September 23, 2026Moderate risk

  Medline Industries, LP : Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

  Medline Industries is recalling its ANESTHESIA PAIN PK LEAGUE DYNJ67925A convenience kits. The kits may have open seals in sterile packaging, risking contamination and patient infection. Consumers should inspect the packaging for open seals and not use affected kits.

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• openFDA · September 23, 2026Moderate risk

  PTW FREIBURG : Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

  The recall affects VERIQA RT MonteCarlo 3D v3 software, model S070031.520, version 3.1.18, from PTW FREIBURG. The software may not clearly show a bolus in treatment plans, causing radiation to be delivered to the wrong tissue depth for patients. Consumers should contact their treatment provider to ensure the software is updated or corrected.

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• openFDA · September 23, 2026Moderate risk

  NOXBOX LTD : NOxBOXi Nitric Oxide Delivery System.

  The recall affects the NOxBOXi Nitric Oxide Delivery System by NOXBOX Ltd. Leaks in the oxygen tubing or connections can cause oxygen desaturation in patients using the device. Consumers should follow the firm's voluntary recall instructions.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : IV Sets with drip chambers

  ICU Medical, Inc. is recalling IV sets with drip chambers. The drip chambers may contain black specks or discolored material that could enter the fluid path, exposing patients to particulate matter. Consumers should consult the recall notice for instructions.

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• openFDA · September 23, 2026Moderate risk

  Medline Industries, LP : Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

  Medline Industries is recalling its Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A. The kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to patient infection. Consumers should check the packaging for open seals and contact Medline Industries for further instructions.

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• openFDA · September 23, 2026High risk

  AVID Medical, Inc. : Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;

  AVID Medical, Inc. is recalling its Haylard BASIC BIOPSY TRAY, model PM415. The kits may have sterility and quality issues due to included Sodium Chloride ampules recalled by Spectra Medical, posing a risk to patients. Consumers should stop using the tray and follow the recall instructions for return or replacement.

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• openFDA · September 23, 2026Moderate risk

  Maquet Cardiopulmonary Gmbh : Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

  Maquet Cardiopulmonary GmbH is recalling its Percutaneous Insertion Kit (PIK) with Guidewire 150 cm, model numbers 701053069 (USA) and 701047385 (OUS). The packaging may not consistently maintain sterile barrier integrity, exposing patients and healthcare providers to infection risk. Consumers should follow the firm's voluntary recall instructions for the affected kits.

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• openFDA · September 23, 2026High risk

  Abiomed, Inc. : Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1.…

  Abiomed is recalling its Impella Optical Controller, Automated Impella Controller, and Impella Connect Package devices. The purge flag component in the purge pressure sensor assembly may fail, causing purge cassette recognition issues and exposing patients to risk. Consumers should contact Abiomed or their healthcare provider for instructions.

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• openFDA · September 23, 2026Moderate risk

  Boston Scientific Corporation : Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort…

  Boston Scientific Corporation is recalling the power adaptor for its StoneSmart Connect Console. The adaptor may have higher-than-expected grounding resistance, causing it to fail electrical safety testing, affecting users worldwide. The recall is voluntary and firm-initiated, so consumers should follow the recall notice.

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• openFDA · September 23, 2026High risk

  Medline Industries, LP : Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4)…

  Medline Industries is recalling certain Medline Convenience Kits, including blood and urine collection kits, with specific catalog numbers. The kits contain sterile applicators that may have fungal contamination, which can cause serious infection, sepsis, or death in patients. Consumers should stop using affected kits, check the catalog numbers, and follow the recall instructions for return or replacement.

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• openFDA · September 23, 2026High risk

  Medline Industries, LP : Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE…

  Medline Industries is recalling certain Convenience Kits, including Open Heart Adult, Full Line Aneurysm CDS, and Non Sterile Chest Tube Removal. The kits contain sterile applicators that may be contaminated with Aspergillus penicillioides, posing a risk of serious infection, sepsis, or death to patients. Consumers should stop using the affected kits and contact Medline Industries for return instructions.

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• openFDA · September 23, 2026Moderate risk

  GE Healthcare : Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

  GE Healthcare's Centricity Enterprise Archive V2, V3, and V4 software, all versions, is affected. The hazard is that historical imaging data may be incorrectly associated with a different patient, exposing patients to misdiagnosis or delayed care. Consumers should contact their healthcare provider to verify their imaging records.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : IV Non-Dedicated Gravity Administration Sets with drip chambers

  ICU Medical, Inc. is recalling its IV Non-Dedicated Gravity Administration Sets with drip chambers. The drip chamber walls may contain black specks of discolored PVC that, if seen by a healthcare provider, could lead to product replacement and delayed patient therapy. Healthcare providers should replace affected sets before use to avoid delays in treatment.

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• openFDA · September 23, 2026Moderate risk

  Howmedica Osteonics Corp. : TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

  Howmedica Osteonics Corp. is recalling its TRIDENT 0° POLY INSERT 28mm ID 620-00-28D orthopaedic implant components made from UHMWPE polyethylene. The affected devices may have elevated oxidation causing increased wear, debris, fracture, or disassociation, leading to revision surgery, pain, and inflammation for patients worldwide. Patients should contact their healthcare provider to confirm if their implant is affected and discuss next steps.

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• openFDA · September 23, 2026Moderate risk

  Howmedica Osteonics Corp. : OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

  Howmedica Osteonics Corp. is recalling its OMNIFIT SERIES I ACET. INSERT 10° 22mm ID Catalog No. 2001-2246 orthopaedic implant components made from UHMWPE. The affected implants may have elevated oxidation from aged raw material, causing increased wear, debris, fracture, or dissociation, which can lead to revision surgery, pain, and inflammation for patients. Patients who have this implant should contact their healthcare provider or the company for further instructions.

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• openFDA · September 23, 2026High risk

  Medline Industries, LP : Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

  Medline Industries is recalling two Convenience Kits, catalog numbers DYNDH1193 and DYNDH1487A. The kits contain sterile applicators that may have Aspergillus penicillioides fungal contamination, which can cause serious infection, sepsis, or death for users. Consumers should consult the FDA recall notice for affected lot numbers and follow the recall instructions.

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• openFDA · September 23, 2026High risk

  Abiomed, Inc. : Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code:…

  The affected product is the Abiomed Impella Optical Controller, with product codes 0042-0010-AU, EU, IN, UK, and US. The hazard is potential purge cassette recognition issues due to failure of the purge flag component, exposing patients to device malfunction. Consumers should contact Abiomed or their healthcare provider for recall instructions.

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• openFDA · September 23, 2026Moderate risk

  Maquet Cardiopulmonary Gmbh : Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

  Maquet Cardiopulmonary GmbH is recalling its Percutaneous Insertion Kit (PIK) with Guidewire 100 cm, model numbers 701053068 and 701047384. The packaging may not consistently maintain sterile barrier integrity, exposing patients and healthcare providers to infection risk. Consumers should stop using the affected kits and contact Maquet Cardiopulmonary for replacement or further instructions.

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• openFDA · September 23, 2026Moderate risk

  Wilson-Cook Medical Inc. : Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software…

  Wilson-Cook Medical Inc. is recalling its HEMOSPRAY Endoscopic Hemostat models HEMO-7, HEMO-10, HEMO-7-EU, and HEMO-10-EU. The device may fail to adhere to the endoscope and spray powder, exposing patients undergoing gastrointestinal endoscopy to risk of uncontrolled bleeding. Consumers should follow the updated Instruction for Use provided by the firm.

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• openFDA · September 23, 2026Moderate risk

  Bayer Medical Care, Inc. : MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

  Bayer Medical Care's MEDRAD Stellant FLEX Syringe Kit (catalog FLEXS-150-QFT) used with the Stellant FLEX CT Injection System is affected. The hazard is that some kits may not have been properly sterilized, exposing patients to infection risk. Consumers should stop using the affected kits and contact Bayer Medical Care for instructions.

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• openFDA · September 23, 2026Moderate risk

  PI CARDIA LTD : Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

  The recall affects Pi-Cardia Inc.'s ShortCut transfemoral catheter, model REF Z-A-20.003-US. The positioning arm may detach due to a weld issue, posing a risk to patients undergoing the procedure. Consumers should follow the voluntary recall instructions from Pi-Cardia Inc. to return or replace the device.

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• openFDA · September 23, 2026Moderate risk

  GE Healthcare : Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing,…

  GE Healthcare's Centricity PACS V2, V3, V4, V6, and V7 software is recalled. Under certain conditions, migrated imaging data may appear under the wrong patient record, risking misdiagnosis or delayed care for patients. Users should contact GE Healthcare to obtain instructions for addressing the recall.

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• openFDA · September 23, 2026Moderate risk

  Stryker Sustainability Solutions : REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

  Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model B5LT. The reusable access port system may crack or separate during use, exposing patients and healthcare providers to injury. Consumers should stop using the affected devices and contact Stryker Sustainability Solutions for return and replacement instructions.

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• openFDA · September 23, 2026Moderate risk

  Howmedica Osteonics Corp. : ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL…

  Howmedica Osteonics Corp. recalled certain acetabular cups and constrained inserts made from ultra-high molecular weight polyethylene. The plastic may have elevated oxidation causing wear, fragments, fracture, or separation, leading to revision surgery, pain, and inflammation for implanted patients. Patients should contact their healthcare provider to check if their device is affected and discuss what to do.

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• openFDA · September 23, 2026Moderate risk

  Howmedica Osteonics Corp. : ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm…

  Howmedica Osteonics Corp. is recalling certain orthopedic implant components made from UHMWPE polyethylene, including acetabular inserts, tibial inserts, and other parts. The plastic may have elevated oxidation from aged raw material, causing wear, debris, fracture, or disassociation, leading to pain, inflammation, or revision surgery for implanted patients. Patients should contact their surgeon or healthcare provider to identify if their implant is affected and discuss next steps.

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• openFDA · September 23, 2026Moderate risk

  Mirion Technologies (Capintec), Inc. : Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;

  Mirion Technologies (Capintec) is recalling its Captus 4000e Thyroid Uptake System, models 5430-30151, 5430-30152, and 5430-30154. The tension bolt can fail, causing the spring arm to unexpectedly drop about 25 inches, posing an injury risk to users and patients. Consumers should stop using the affected device and contact Mirion Technologies for repair or replacement.

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• openFDA · September 23, 2026Moderate risk

  Stryker Sustainability Solutions : REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

  Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery XCEL Bladeless Trocar with Stability Sleeve, model REF:B5ST. The reusable access port system may crack or separate during use, exposing patients and surgical staff to injury. Consumers should stop using the affected device and contact Stryker Sustainability Solutions for return and replacement instructions.

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• openFDA · September 23, 2026Moderate risk

  F & A Foundation : Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818;…

  The Reign Medical Clench Staple System (Compression) bone fixation staple is recalled in multiple sizes. The device's performance characteristics have not been adequately established, posing a risk to patients. Consumers should stop using the recalled staples and follow the firm's instructions.

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• openFDA · September 23, 2026Moderate risk

  Howmedica Osteonics Corp. : SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE…

  Howmedica Osteonics Corp. recalled SCORPIO C-DOME and U-DOME PATELLA orthopaedic implant components made from UHMWPE. The aged polyethylene may oxidize and wear excessively, causing debris, fracture, or dissociation, leading to revision surgery, pain, and inflammation in patients worldwide. Patients should contact their orthopaedic surgeon to discuss the recall and next steps.

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• openFDA · September 23, 2026High risk

  Medline Industries, LP : Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

  Medline Industries is recalling its Medline Convenience Kit, the Anesthesia L&D A-Line Set, catalog number DYKMBNDL199A. The kits contain sterile applicators that may have fungal contamination, which can cause serious infection, sepsis, or death in patients. Consumers should stop using the affected kits and contact Medline Industries for instructions.

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• openFDA · September 23, 2026Moderate risk

  Philips North America : Philips PIC iX Essentials REF:867093

  Philips North America is recalling its PIC iX Essentials patient information system, model REF:867093. A software malfunction can freeze the system, affecting patients and healthcare providers who rely on it. Consumers should contact Philips North America for instructions.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : IV Sets with drip chambers

  ICU Medical, Inc. is recalling its IV Sets with drip chambers. The drip chambers may contain black specks or discolored material that could enter the fluid path, posing a risk to patients receiving intravenous therapy. Consumers should contact ICU Medical for instructions.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : Plum administration sets

  ICU Medical Plum administration sets are affected. The drip chambers may contain black specks, and particulate matter in the fluid path has not been ruled out, exposing patients to potential harm. Consumers should stop using the affected sets and contact ICU Medical for instructions.

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• openFDA · September 23, 2026High risk

  Nova Biomedical Corporation : StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.

  The recall affects Nova Biomedical's StatStrip Glucose Hospital Meter System, model 63685. A software timing issue can keep a previous patient's barcode on screen, so glucose results may be assigned to the wrong patient, endangering critically ill patients, neonates, and infants. Users should follow the recall notice from Nova Biomedical for return and correction instructions.

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• openFDA · September 23, 2026High risk

  Nova Biomedical Corporation : StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.

  Nova Biomedical is recalling its StatStrip Glucose and B-Ketone meter, model 63683, a glucose test system. A software timing issue can keep a previous patient's barcode on screen, so a current patient's glucose result may be saved to the wrong medical record, affecting critically ill patients, neonates, and infants. Nova Biomedical initiated a voluntary recall; users should contact the company for instructions.

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• openFDA · September 23, 2026High risk

  AVID Medical, Inc. : Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

  AVID Medical, Inc. is recalling Haylard UNIV IMAGING BIOPSY TRUCUSTOM kits, model VARV042-03. The kits may have product quality and sterility issues because they contain Sodium Chloride ampules recalled by Spectra Medical, posing a risk to patients. Consumers should stop using the affected kits and contact AVID Medical for further instructions.

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• openFDA · September 23, 2026High risk

  Abiomed, Inc. : Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code:…

  Abiomed is recalling its Automated Impella Controller (AIC) devices with specific product codes. The purge flag component in the purge pressure sensor assembly can fail, leading to purge cassette recognition issues that put patients at risk. Consumers should contact Abiomed or their healthcare provider to arrange for corrective action.

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• openFDA · September 23, 2026Moderate risk

  GE Healthcare : Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

  GE Healthcare's Centricity PACS Server V7, all versions, is affected. The hazard is that migrated images may be linked to the wrong patient, risking misdiagnosis or delayed care for patients. Users should contact GE Healthcare to arrange for corrective action.

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• openFDA · September 23, 2026Moderate risk

  Happiest Baby, Inc : Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110

  The affected product is the Happiest Baby, Inc SNOO Sleep Sack, X-Small, with model numbers S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, and S2107-110. The hazard is that these extra small and extra large infant sleep sacks have not been reviewed for safety and effectiveness by the FDA, exposing infants to potential unverified risks. Consumers should stop using the recalled sleep sacks and contact Happiest Baby, Inc for further instructions.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : IV Sets with drip chambers

  ICU Medical is recalling IV sets with drip chambers. The drip chambers may contain black specks or discolored material that could enter the fluid path, exposing patients to particulate matter. Consumers should stop using affected sets and contact ICU Medical for instructions.

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• openFDA · September 23, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

  Medline Industries is recalling its Medline Convenience Kit: OPEN HEART A PACK, product number DYNJ43008N. The kit contains a cannula with a possible sterile barrier breach, exposing patients to risk of infection or other complications. Consumers should check the pouch seal before use and contact Medline if it is compromised.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : Oncology sets with drip chambers

  ICU Medical oncology sets with drip chambers are affected. The drip chamber walls may contain black specks, which could lead healthcare providers to replace the product and delay patient therapy. Consumers should follow the recall instructions from ICU Medical.

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• openFDA · September 23, 2026Moderate risk

  Datex-Ohmeda, Inc. : Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

  The recall affects the Aisys CS2 Datex-Ohmeda anesthesia system, part number 1011-9055-000. The device can switch to Alternate O2 control, interrupting anesthetic delivery and risking reduced anesthetic effect for patients unless a clinician intervenes. Users should stop using affected units and contact Datex-Ohmeda for corrective instructions.

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• openFDA · September 23, 2026Moderate risk

  ICU Medical, Inc. : Oncology sets with drip chambers

  ICU Medical oncology sets with drip chambers are affected. The drip chamber walls may have black specks from molding, which healthcare providers might see and replace the product, delaying therapy for patients. Consumers should have the product replaced before use if black specks are seen.

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• openFDA · September 23, 2026High risk

  Nova Biomedical Corporation : StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

  The affected product is the Nova Biomedical StatStrip Glucose and B-Ketone meter, model 63910, glucose test system. A software timing issue can retain a previous patient or QC barcode, causing glucose results to be assigned to the wrong patient record, exposing critically ill patients, neonates, and infants to inappropriate treatment. Users must confirm the displayed patient ID matches the current patient before accepting any test result.

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• openFDA · September 23, 2026Moderate risk

  GE Medical Systems Information Technologies Inc : Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product…

  GE Medical Systems Information Technologies Inc is recalling its Carescape Central Station CSCS V3 MAS800 Desktop and MAI800 Integrated devices. The devices may fail to resume patient monitoring for at least 3 minutes after a system restart, potentially delaying recognition of clinically significant events for patients. Consumers should contact GE Medical Systems Information Technologies Inc for instructions on how to address this issue.

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• openFDA · September 23, 2026High risk

  Medline Industries, LP : Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

  Medline Industries is recalling its Convenience Kits with catalog numbers DYKM1000B and DYKM2187A. The kits contain sterile applicators that may have fungal contamination, exposing patients to risk of serious infection, sepsis, and death. Consumers should review the FDA recall notice and follow the firm's instructions.

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• openFDA · September 23, 2026High risk

  AVID Medical, Inc. : Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;

  AVID Medical is recalling its Haylard 18G Single Shot Epi Tray, model DPGE002-02. The kits contain Sodium Chloride ampules with potential quality and sterility issues, posing a risk to patients. Consumers should stop using the affected trays and contact AVID Medical or their healthcare provider for instructions.

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• openFDA · September 23, 2026Moderate risk

  Datex-Ohmeda, Inc. : Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU)…

  Datex-Ohmeda, Inc. is recalling its Et Control software option for anesthesia gas machines, including field replaceable units 1011-8000-000-S and 5700665. The affected systems can switch to Alternate O2 control, interrupting anesthetic agent delivery and requiring clinician intervention; without it, patients may experience decreased anesthetic effect. Clinicians must intervene if the system switches to Alternate O2 control, to prevent the patient from experiencing decreased anesthetic agent effect.

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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.