Use cautionMedical device recall · FDA · Published August 3, 2020
Smith & Nephew Single RIKKI Retractor Recall: Improper Heat Treatment Hazard
Smith & Nephew recalls Single RIKKI retractors with specific lot numbers due to improper heat treatment. These surgical tools may fail during use, risking injury to patients or staff.
“Smith & Nephew Single RIKKI Retractor Recall: Improper Heat Treatment Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64559-smith-nephew-single-rikki-retractor-recall-improper-heat-treatment-hazard. Based on FDA recall #Z-2818-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2818-2020%22&limit=1).
Smith & Nephew, Inc. recalled Single RIKKI Retractors due to improper heat treatment, the FDA said on Aug. 3, 2020. Owners should contact the company for a replacement.
How to tell if you have it
Brand: Smith & Nephew
Product: Single RIKKI Retractor
Catalog #: 71934609
Lot numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520
Units affected: 111
The hazard
The products were improperly heat treated.
Context
GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include the Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025), Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), and Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026).
How to tell if you have this one
Check the lot number on the retractor. The recalled items have lot numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the retractor to determine if it is recalled.
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Connecticut, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Massachusetts, New York, North Carolina, Oklahoma, Pennsylvania, South Dakota, Tennessee, Washington, Wisconsin.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2818-2020 (August 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2818-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.