Quick Facts at a Glance
- Recall Date
- February 11, 2026
- Hazard Level
- HIGH
- Brand
- Waldemar Link GmbH & Co. KG
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Waldemar Link GmbH & Co. KG
- Product type
- Drill Tower (Shoulder Instrument)
- Model numbers
- Item Number: Item Number: 645-081/62, UDI: 04026575534715, Lot Number: All Lots
- Sizes
- 25mm
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 11, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: E-Mail
About This Product
This device is part of the Embrace shoulder instrumentation used in orthopedic procedures. It is a wedged drill tower component used in shoulder surgery.
Why This Is Dangerous
The mislabeling of article numbers could lead to incorrect instrument identification during procedures, which may compromise patient safety.
Industry Context
This recall is not indicated as part of a broader industry pattern in the available data.
Real-World Impact
Healthcare providers may need to verify instrument IDs before use, potentially causing procedural delays.
Practical Guidance
How to identify if yours is affected
- Verify item number 645-081/62
- Cross-check UDI 04026575534715 with recall records
- Inspect labeling and documentation for discrepancies
Where to find product info
Recall notice and UDI can be referenced in FDA enforcement records linked to Z-1651-2026
What timeline to expect
Processing times for replacement or disposition are determined by the manufacturer and healthcare facilities
If the manufacturer is unresponsive
- Escalate to hospital compliance or medical device reporting channels
- File a MedWatch report if patient harm is suspected
How to prevent similar issues
- Always verify device labeling against official recall notices
- Maintain an updated inventory of orthopedic instrument IDs
- Establish a double-check protocol for instrument IDs before procedures
Documentation advice
Keep copy of recall notice, email communications, and any disposition records for the device
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Product Details
Model/Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; Quantity: 75 units; Distributed to: 15 US states (AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA); Sold to: Hospitals and surgical centers; Recall date: 2026-02-11; Status: Active; Manufacturer: Waldemar Link GmbH & Co. KG; Manufacturer site: Germany; Distribution: US.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All lots affected
- States: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Immediate action required: stop using
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Safety Guide
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