Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is

Recall overview

What This Recall Notice Says

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Before you act: a similar product name is not enough. Match the identifiers, affected dates, model or lot details, and remedy instructions in the official notice.

1. Match the item

Check device name, UDI, model, lot, serial and software version.

2. Read the risk

Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.

3. Follow the remedy

Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.

4. Verify officially

Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.

How To Tell If Yours Is Included

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.

Recall Hazard And Risk

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Recall Remedy

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.

Affected Product Or Item

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the C

Hazard Or Reason For Recall

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Official Recall Facts

SourceFDA
Recall numberZ-1134-2026
CategoryMedical Device
RiskHigh
StatusOngoing
PublishedJan 28, 2026
Recall dateDec 4, 2025
CompanyIntuitive Surgical, Inc.
Affected units110580

Identifiers To Match

Lot/code infoLot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014 Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 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DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1231702 DM1231702 DM1231702 DM1231702 DM1230443 DM1231355 DM1232006 Part Number: 490127-02 Batch Numbers: DM01252527 DM01252527 DM01252527 DM01252527 DM01242617 DM01244230 DM01241638 DM01241638 DM01240221 DM01240221 DM01240221 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253002 DM01253002 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253518 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253518 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM0125300
CODE_INFOLot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014 Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM0
FDA_EVENT98215

Where Sold Or Distributed

U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom CA

How To Check If This Recall Applies To You

Match The Device Label

Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.

Compare Codes And Date Ranges

Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.

Read The Hazard Before Use

Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.

Follow The Official Remedy

Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.

Key Medical Device Recall Checks

Use these checks to decide whether the notice is relevant to the item you have, then confirm with the official source.

Identity

UDI, Model, Lot And Serial

Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.

Risk

Hazard, Consequence And Risk Level

Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.

Action

Repair, Replacement, Refund Or Disposal

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.

Source

Official Agency Notice

This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.

Related Product Recalls

More recalls from the same category.

Browse Category

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

Recall Detail FAQ

Short answers for checking whether this recall notice applies to your item.

How do I know if this recall affects my product?

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.

What should I do after finding a matching recall?

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.

Is this page the official recall notice?

No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.

Why can a recall page change after publication?

Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.

Confirm With The Official Notice

What This Recall Notice Says

How To Tell If Yours Is Included

Recall Hazard And Risk

Recall Remedy

Affected Product Or Item

Hazard Or Reason For Recall

How To Check If This Recall Applies To You

Match The Device Label

Compare Codes And Date Ranges

Read The Hazard Before Use

Follow The Official Remedy

Key Medical Device Recall Checks

UDI, Model, Lot And Serial

Hazard, Consequence And Risk Level

Repair, Replacement, Refund Or Disposal

Official Agency Notice

Related Product Recalls

Recall Detail FAQ

How do I know if this recall affects my product?

What should I do after finding a matching recall?

Is this page the official recall notice?

Why can a recall page change after publication?