Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,476 - 1,500 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02 Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.	FDA Z-1175-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 29, 2025	Details
Alphenix INFX-8000H, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed	FDA Z-1178-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 19, 2025	Details
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1117-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 Incorrect expiration date	FDA Z-1218-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 5, 2025	Details
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT . Potential exposure of rodents and rodent activity in the distribution center.	FDA Z-1181-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 26, 2025	Details
Genesis Dual Thread Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1169-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1116-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
AlternatiV+ Max Knotless Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1172-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1214-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964. Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.	FDA Z-1197-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1211-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO SHUNT BUMC, Kit SKU DYNJT6428. Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.	FDA Z-1196-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034; Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.	FDA Z-1187-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1210-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1216-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.	FDA Z-1201-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 24, 2025	Details
Alphenix INFX-8000F, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed	FDA Z-1177-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 19, 2025	Details
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F. Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.	FDA Z-1199-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1205-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct. Potential exposure of rodents and rodent activity in the distribution center.	FDA Z-1183-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 26, 2025	Details
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 Incorrect expiration date	FDA Z-1165-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 29, 2025	Details
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).	FDA Z-1212-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT. Potential exposure of rodents and rodent activity in the distribution center.	FDA Z-1182-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 26, 2025	Details
Genesis Knotless Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1170-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Ch The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.	FDA Z-1203-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 26, 2025	Details

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Medical Device Recalls Today

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