FDA Medical Device Recalls (openFDA)
Medela Inc: Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
- Recall number
- Z-2553-2011
- Recalling firm
- Medela Inc
- Product
- Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
- Status
- Terminated
- Initiated
- 2011-05-18
- Posted
- 2011-06-10
- Terminated
- 2012-02-16
- Reason
- The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
- Root cause
- Packaging
- Action
- The firm, Medela, sent an "Important Device Recall" letter dated May 9, 2011 to all of their customers/direct accounts. Medala also began telephoning or visiting the direct accounts/customers on May 18, 2011. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lots and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form inlcude with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or email jim.hughes@medela.com, even if they have no affected product on hand 5)If you have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. Each affected product will be replaced with (2) non-sterile nipple shields. 5) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. Questions about the recall process were directed to Medela Customer Service at 1-888-835-5968 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.
- Quantity
- 4,320 units
- Distribution
- Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV.
- Lot, serial or model codes
- article number 67203S, lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HFS
- Firm FEI
- 1419937
- Firm city
- Mchenry
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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