Covidien LP: Covidien 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, transection, and creation of anastomosis

Recall number

Z-1844-2012

Recalling firm

Covidien LP

Product

Covidien 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, transection, and creation of anastomosis

Status

Terminated

Initiated

2012-05-09

Posted

2012-06-21

Terminated

2014-02-12

Reason

Potential for the sterility barrier to be compromised.

Root cause

Package design/selection

Action

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: SDFeedback@Covidien.com, 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 SDFeedback@Covidien.com 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.

Quantity

50698 units

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.

Lot, serial or model codes

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

510(k) numbers

["K855047"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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