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 (Surgical Instrument)
- Model numbers
- Item Number: Item Number: 645-081/62, UDI: 04026575534715, Lot Number: All Lots
- 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
The Embrace Shoulder Instruments are used in orthopedic shoulder procedures. The Drill Tower is a component used during surgical steps.
Why This Is Dangerous
A mismatch between article numbers in the instrument overview may lead to incorrect instrument identification during procedures. The steps remain correct, but mislabeling could affect device selection.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
74 devices recalled in the United States across 15 states. Immediate action required to prevent potential procedural errors.
Practical Guidance
How to identify if yours is affected
- Verify item numbers against the recall notice: 645-081/63 and 645-081/62.
- Check UDI 04026575534715 for mislabeling alerts.
- Review the recall email from Waldemar Link for instructions.
Where to find product info
FDA enforcement report page for Z-1652-2026 provides the official recall notice.
What timeline to expect
No specific refund timeline provided in the notice.
If the manufacturer is unresponsive
- Escalate to Waldemar Link via email, if available.
- Coordinate with your healthcare facility for guidance and possible alternatives.
How to prevent similar issues
- Verify instrument labeling before use.
- Cross-check item numbers with official recall notices.
- Maintain updated records of instrument configurations in surgical kits.
Documentation advice
Keep recall notice, email communications, and any replacement instructions for records.
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Product Details
Model numbers: 645-081/63 (primary) and 645-081/62 (related). UDI: 04026575534715. Sold in the United States to AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA. Recall date: 2026-02-11. Quantity: 74 units. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 74 units
- US distribution states: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Item Numbers: 645-081/63 and 645-081/62
- Recall status: ACTIVE
- Hazard type: Mixed-up article numbers in instrument overview; surgical steps correct
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Safety Guide
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