Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,501 - 1,525 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Ingenia 3.0T CX. Product Code (REF): 781271. 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-1208-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
MR 7700. Product Code (REF): (1) 782120, (2) 782153. 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-1213-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. 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-1207-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS 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-1202-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 24, 2025	Details
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ07 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-1193-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B 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-1194-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A. 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-1195-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Fixone Hybrid Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1166-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
Fixone Biocomposite Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1167-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
BEAR Implant. Model Number: 1000. Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.	FDA Z-1220-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 31, 2025	Details
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. 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-1204-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 1 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-1191-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A. 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-1189-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE 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-1115-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; 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-1174-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 29, 2025	Details
Ingenia Ambition S. Product Code (REF): 782108. 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-1209-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Genesis Push-In Suture Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1171-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
SmartPath to dStream for 3.0T. Product Code (REF): 782145. 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-1215-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 3, 2025	Details
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713 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-1186-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
AlternatiV+ Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	FDA Z-1173-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 17, 2025	Details
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOP 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-1200-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 12, 2025	Details
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.	FDA Z-1219-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 22, 2025	Details
SQ40S Blood Transfusion Filter Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.	FDA Z-1157-2026	Medical Device	High	Jan 28, 2026 Recall: Nov 3, 2025	Details
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.	FDA Z-1147-2026	Medical Device	High	Jan 28, 2026 Recall: Oct 24, 2025	Details
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4 Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.	FDA Z-1011-2026	Medical Device	High	Jan 28, 2026 Recall: Nov 26, 2025	Details

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Medical Device Recalls Today

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