Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Use this page to screen for a possible match. Use the linked official notice before you stop use, throw away, return, repair or schedule service.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Check device name, UDI, model, lot, serial and software version.
Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.
Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.
Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.
Device recalls can depend on UDI, model, catalog number, lot, serial number, software version or implant card details. Match the label before changing device use.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Use the official notice for remedy instructions. Product recall remedies may include repair, replacement, refund, disposal, software update, dealer service or a stop-use instruction.
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.
Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.
Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.
Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.
Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.
Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.
Recall remedies differ by agency and product type. The official notice is the final source for repair, refund, replacement, disposal, dealer service or stop-use steps.
This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.
| 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 |
Compare the product name, brand, model, UPC, lot code, serial number, VIN, date code, package size, retailer and distribution details with the official notice. All key details should match.
Stop using, feeding, driving or consuming the product when the notice says to do so, then follow the official remedy for repair, replacement, refund, disposal, service or company contact.
No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.
Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.