Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1 - 25 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.	FDA Z-2714-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 5, 2026	Details
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.	FDA Z-2696-2026	Medical Device	High	Jul 15, 2026 Recall: May 28, 2026	Details
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty. Due to packaging discrepancy with incorrect product size mixed up.	FDA Z-2701-2026	Medical Device	High	Jul 15, 2026 Recall: Feb 16, 2026	Details
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty. Due to packaging discrepancy with incorrect product size mixed up.	FDA Z-2700-2026	Medical Device	High	Jul 15, 2026 Recall: Feb 16, 2026	Details
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.	FDA Z-2697-2026	Medical Device	High	Jul 15, 2026 Recall: May 28, 2026	Details
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.	FDA Z-2694-2026	Medical Device	High	Jul 15, 2026 Recall: Apr 22, 2026	Details
VITEK 2 AST-N447 TEST KIT Product reference 424620 Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.	FDA Z-2715-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 4, 2026	Details
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.	FDA Z-2716-2026	Medical Device	High	Jul 15, 2026 Recall: May 8, 2026	Details
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy. Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.	FDA Z-2712-2026	Medical Device	High	Jul 15, 2026 Recall: Apr 3, 2026	Details
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy. Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.	FDA Z-2711-2026	Medical Device	High	Jul 15, 2026 Recall: Apr 3, 2026	Details
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8. Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.	FDA Z-2702-2026	Medical Device	High	Jul 15, 2026 Recall: May 11, 2026	Details
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium. Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.	FDA Z-2710-2026	Medical Device	High	Jul 15, 2026 Recall: Apr 3, 2026	Details
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.	FDA Z-2703-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 8, 2026	Details
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.	FDA Z-2695-2026	Medical Device	High	Jul 15, 2026 Recall: May 28, 2026	Details
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.	FDA Z-2717-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 9, 2026	Details
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.	FDA Z-2676-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 5, 2026	Details
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).	FDA Z-2698-2026	Medical Device	High	Jul 15, 2026 Recall: May 27, 2026	Details
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, A product error defect may cause incorrect bracket placement.	FDA Z-2699-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 8, 2026	Details
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.	FDA Z-2713-2026	Medical Device	High	Jul 15, 2026 Recall: May 18, 2026	Details
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R Surgical dressing manufactured out of specification (greater thickness).	FDA Z-2677-2026	Medical Device	High	Jul 15, 2026 Recall: Jun 8, 2026	Details
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; 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-2549-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A 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-2545-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: 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-2536-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; 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-2548-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
ARTIS icono ceiling. Model Number: 11328100. Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.	FDA Z-2642-2026	Medical Device	High	Jul 8, 2026 Recall: May 20, 2026	Details

Showing 1 - 25 of 1,678 product recalls

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Medical Device Recalls Today

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