Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,226 - 1,250 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Software anomaly in the patient positioning system may result in positional discrepancy.	FDA Z-1429-2026	Medical Device	High	Mar 4, 2026 Recall: Feb 6, 2026	Details
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1452-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 Knee and Humeral socket implants contain incorrect labeling.	FDA Z-1460-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 15, 2026	Details
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1448-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 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-1467-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200 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-1463-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 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-1434-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 5, 2026	Details
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1444-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.	FDA Z-1473-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 13, 2026	Details
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1439-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1447-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1446-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1455-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1445-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741 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-1465-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1450-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light Due to battery component overheating while charging resulting in melting of internal components and causing smoke.	FDA Z-1436-2026	Medical Device	High	Mar 4, 2026 Recall: Oct 13, 2025	Details
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1442-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432 Knee and Humeral socket implants contain incorrect labeling.	FDA Z-1458-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 15, 2026	Details
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received.	FDA Z-1454-2026	Medical Device	High	Mar 4, 2026 Recall: Nov 11, 2025	Details
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 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-1468-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 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-1464-2026	Medical Device	High	Mar 4, 2026 Recall: Jan 8, 2026	Details
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events.	FDA Z-1376-2026	Medical Device	High	Feb 25, 2026 Recall: Oct 22, 2025	Details
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Firm is initiating a removal due to continued reports of adverse events.	FDA Z-1379-2026	Medical Device	High	Feb 25, 2026 Recall: Oct 22, 2025	Details
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108 Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.	FDA Z-1386-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 7, 2026	Details

Showing 1,226 - 1,250 of 1,678 product recalls

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Medical Device Recalls Today

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Recall Class And Risk Level

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

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Read The Recall Hazard

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Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.