Covidien ROTICULATOR 30-3.5 Single Use Stapler recallZ-1846-2012 · Covidien LP · initiated May 9, 2012
Class II Terminated All recalls posted in June 2012
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 Covidien LP 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
Potential for the sterility barrier to be compromised.
FDA root cause category: Package design/selection
What the company is doing
The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2012 via federal express to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (note: units from affected lots may have been incorporated into Covidien BEST PRACTICE KITS; evaluate kits for affected lots). All affected ROTICULATOR units must be returned. The customers were also instructed to complete and return the attached ROTICULATOR Single Use Stapler Recalled Product Return form via fax to: (800) 895-6140 or email to: [email protected], even if you do not have any of the affected units, and include a copy of completed form with products being returned. Customers who received product directly from Covidien should contact Covidien Customer Service at [email protected] or (800) 722-8772, option 1, prior to returning affected products to Covidien, Field Returns Department, at 195 McDermott Road, North Haven, CT 06473; if received from distributor, return form and contact distributor directly. If you have any questions or concerns, please do not hesitate to contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.
Recall details
- Recall number
- Z-1846-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 9, 2012
- Posted by the FDA
- Jun 21, 2012
- Recalling firm
- Covidien LP
- Quantity
- 13531 units
- Product code
- GDW
- FDA submissions
- K855047
- Distribution
- Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
Product description
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code information (models, lots, serial numbers)
LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Other devices under the same FDA submission
11 devices cleared under K855047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Roticulator 017614Covidien LP · STAPLE, IMPLANTABLE35 reports
- Roticulator 017619Covidien LP · STAPLE, IMPLANTABLE8 reports
- Roticulator 017617Covidien LP · STAPLE, IMPLANTABLE7 reports
- TA Premium 015451LCovidien LP · STAPLE, IMPLANTABLE5 reports
- TA Premium 015458LCovidien LP · STAPLE, IMPLANTABLE4 reports
- TA Premium 015441LCovidien LP · STAPLE, IMPLANTABLE3 reports
- Roticulator 017612Covidien LP · STAPLE, IMPLANTABLE3 reports
- TA Premium 015485LCovidien LP · STAPLE, IMPLANTABLE2 reports
- TA Premium 015427LCovidien LP · STAPLE, IMPLANTABLE1 report
- TA Premium 015433LCovidien LP · STAPLE, IMPLANTABLE1 report
- TA Premium 015477LCovidien LP · STAPLE, IMPLANTABLE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 61942).
- Z-1844-2012 · TerminatedCovidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,…
- Z-1845-2012 · TerminatedCovidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection…
- Z-1847-2012 · TerminatedCovidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection…
- Z-1848-2012 · TerminatedCovidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,…
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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