Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 51 - 75 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
CRE Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2637-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2663-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CRE Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2632-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2665-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.	FDA Z-2551-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.	FDA Z-2620-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2655-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B; Part Number: 151730418. 6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B; Part Number: 151730420. 7. ATTUNE KNEE The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.	FDA Z-2617-2026	Medical Device	High	Jul 8, 2026 Recall: May 19, 2026	Details
ARTIS icono floor. Model Number: 11327700. Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.	FDA Z-2643-2026	Medical Device	High	Jul 8, 2026 Recall: May 20, 2026	Details
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.	FDA Z-2674-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 9, 2026	Details
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.	FDA Z-2622-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.	FDA Z-2535-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CRE Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2636-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CRE Wireguided 12-15mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2635-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.	FDA Z-2544-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod). External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.	FDA Z-2604-2026	Medical Device	High	Jul 8, 2026 Recall: May 20, 2026	Details
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.	FDA Z-2638-2026	Medical Device	High	Jul 8, 2026 Recall: Apr 21, 2026	Details
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L C Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.	FDA Z-2613-2026	Medical Device	High	Jul 8, 2026 Recall: May 28, 2026	Details
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.	FDA Z-2644-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 16, 2026	Details
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2658-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CRE Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2633-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement	FDA Z-2463-2026	Medical Device	High	Jul 8, 2026 Recall: May 29, 2026	Details
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.	FDA Z-2533-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
CRE Pro Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2626-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Due to catheter separation	FDA Z-2672-2026	Medical Device	High	Jul 8, 2026 Recall: May 19, 2026	Details

Showing 51 - 75 of 1,678 product recalls

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Medical Device Recalls Today

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How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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