Smith & Nephew, HD1200 Autoclavable Camera Head recallZ-0082-2012 · Smith & Nephew, Inc. Endoscopy Division · initiated Sep 23, 2011
Terminated All recalls posted in October 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
HD1200 camera heads may cause image issues
FDA root cause category: Process design
What the company is doing
Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to [email protected]. For questions call 405-917-8556.
Recall details
- Recall number
- Z-0082-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 23, 2011
- Posted by the FDA
- Oct 21, 2011
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 15 units
- Product code
- GCJ
- FDA submissions
- K014158
- Distribution
- Nationwide Distribution (USA) including the states of: MI, NH, OK.
Product description
Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
Code information (models, lots, serial numbers)
S/N: DDQ00051, DDQ00052, DDQ00057 DDQ00064, DDQ00068, DDQ00070 DDQ00071, DDQ00080, DDQ00083 DDQ00085, DDQ00093, DDQ00094 DDQ00096, DDQ00104, DDQ00108
Other devices under the same FDA submission
3 devices cleared under K014158 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HD 1200 72203360Smith & Nephew, Inc. · Laparoscope, general & plastic surgery5 reports
- NA 72203360SSmith & Nephew, Inc. · Laparoscope, general & plastic surgery4 reports
- NA 72203361SSmith & Nephew, Inc. · Laparoscope, general & plastic surgery1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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