Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,201 - 1,225 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.	FDA Z-1469-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 27, 2026	Details
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. Potential for rubber fragment detachment during use.	FDA Z-1489-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 29, 2026	Details
Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.	FDA Z-1470-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 27, 2026	Details
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. Potential for rubber fragment detachment during use.	FDA Z-1488-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 29, 2026	Details
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.	FDA Z-1472-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 21, 2026	Details
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.	FDA Z-1432-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 5, 2026	Details
PIE Trolley System Model: 2005 Lack of 510K clearance	FDA Z-1461-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 14, 2026	Details
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1451-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR Software anomaly in the patient positioning system may result in positional discrepancy.	FDA Z-1430-2026	Medical Device	High	Mar 4, 2026 Recall: Feb 6, 2026	Details
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.	FDA Z-1466-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1456-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1438-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.	FDA Z-1433-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 5, 2026	Details
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.	FDA Z-1431-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 5, 2026	Details
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707 Knee and Humeral socket implants contain incorrect labeling.	FDA Z-1459-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 15, 2026	Details
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.	FDA Z-1437-2026	Medical Device	High	Mar 4, 2026 Recall: Sep 13, 2024	Details
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1443-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Campy CVA Medium 100/PK, R01272 Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.	FDA Z-1474-2026	Medical Device	High	Mar 4, 2026 Recall: Feb 5, 2026	Details
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1441-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1453-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1457-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
PIE PAK Models: P2HC-A, P2HC-S, P2HC Lack of 510K clearance	FDA Z-1462-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 14, 2026	Details
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1440-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.	FDA Z-1435-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 5, 2026	Details
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1449-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details

Showing 1,201 - 1,225 of 1,678 product recalls

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Medical Device Recalls Today

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