CooperSurgical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2054-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 10, 2017

Date Posted: May 17, 2017

Recall Number: Z-2054-2017

Event ID: 76980

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.

Status: Terminated

Product Quantity: 7126 units (total for all products)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated