Smiths Medical Graseby 3300 Pump Recall: Key Mismatch Risk
Smiths Medical recalls Graseby 3300 Patient Controlled Syringe Pumps with mismatched lock and key. Affected models include 0128-0001 to 069850. Contact for remedy.
Lower-risk recall
In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Contact the company
What happened, in plain English
Smiths Medical is recalling Graseby 3300 Patient Controlled Syringe Pumps because the lock and key supplied may not match the standard key. This mismatch could prevent proper operation of the pump, potentially causing unsafe infusion delivery. Read more at govinfonow.com/recall/73122-smiths-medical-graseby-3300-pump-recall-key-mismatch-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73122-smiths-medical-graseby-3300-pump-recall-key-mismatch-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0497-2018
Cite this page
“Smiths Medical Graseby 3300 Pump Recall: Key Mismatch Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73122-smiths-medical-graseby-3300-pump-recall-key-mismatch-risk. Based on FDA recall #Z-0497-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0497-2018%22&limit=1).
Why it’s dangerous
The lock and key supplied with the pump may not match the standard key. This mismatch could prevent the pump from operating correctly, leading to unsafe infusion delivery if the key is not properly engaged.
Who’s affected
Patients using Graseby 3300 Patient Controlled Syringe Pumps for infusion therapy are affected. Those with the specific model numbers listed are most at risk.
How to tell if you have this one
Check for model numbers 0128-0001, 0128-0025, 0128-0135, 0128-0136, or 0128-0451 on the pump. The recall includes specific lot/serial numbers listed in the record.
- Brand
Smiths Medical- Category
Medical device
What to do — step by step
Check Model Number
Identify the model number on the pump to see if it matches the affected list (0128-0001, 0128-0025, etc.).
Contact Manufacturer
Reach out to Smiths Medical for guidance on next steps if the pump is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0497-2018 (August 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0497-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.