CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack recalled
Covidien is recalling Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18", distributed nationwide in the US. The recall was initiated on 3 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1854-2016
- FDA event ID
- 73427
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2016
- FDA classified
- 31 May 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Imaging Equipment
Timeline
| 3 Mar 2016 | Recall initiated by company | |
| 31 May 2016 | Classified by FDA | +89 days |
| 8 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Compromised sterility due to breach of barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
Where it was distributed
Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
Questions about this recall
Is Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" recalled?
Yes. Covidien recalled Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" on 3 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1854-2016.
Why was it recalled?
Compromised sterility due to breach of barrier
Which lots are affected?
All lots beginning with 110000161662 through lot 15G255462X
Where was it sold?
Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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