Z-2054-2017Class II

CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball...

Name: Z-2054-2017 CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball...
Creator: CooperSurgical, Inc.
Published: 2017-04-10
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2017-04-10 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary... on 2017-04-10. FDA classified it as Class II and gives the reason as "The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2054-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Posted: 2017-05-09
Terminated: 2017-11-01
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
Product code: HHW Pessary, Vaginal
Reason for recall: The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: CooperSurgical sent a recall notification dated April 10, 2017 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer.
Quantity in commerce: 7126 units (total for all products)
Distribution: Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN
Product codes and lots: 142947 142948 142949 146348 153078 153079 157415 160844 166923 166924 166925 178346 178347 178348 182458 185831 185832 185834 185835 185836 211779 219502 139577 141310 142937 146344 150141 153064 153065 157402 160467 162612 166911 178317 183618 183619 185809 185810 185812 185814 211776 212978 218621 218622 135402 141313 142941 144528 153069 153070 157406 157407 160839 166915 166916 166917 178320 178321 178322 178323 185818 185822 185823 185824 201919 212980 215758 121937 142944 144530 153074 157411 160842 178332 178333 178334 178335 182453 185826 185827 218669 139581 139582 139583 142946 144532 146347 153076 153077 157414 178343 178344 182455 182456 182457 200176 212983 215760

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2054-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2054-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-08

Product code HHW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)