Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator… — Class II medical device recall Z-1240-2013
Terminated recall by Smiths Medical ASD, Inc., reported 2013-05-15, distributed nationwide. Unable to pass catheter through outer sheath during embryo transfer
| Recall number | Z-1240-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-05-03 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2021-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BG, BH, BR, CA, CN, CY, CZ, DE, DK, EG, ES, FI, GB, GH, GR, HK, IE, IL, IT, JO, JP, KR, KW, LB, LK, NG, NL, PK, PL, RO, RU, SA, SG, TR, UA, UY |
| Quantity | 59,089 units |
| Lot numbers | 2000101, 2044006, 2044008, 2044009, 2065654, 2117203, 2117204, 2120950, 2138835, 2152580, 2152582, 2156663, 2165851, 2165852, 2170920, 2170926, 2295309, 2304187, 2304192, 2304193, 2304194, 2304196, 2304197, 2304198, 2305241, 2305243, 2313279, 2324539, 2327973, 2327974, 2336959, 2341411, 2341412, 2341414, 2341415, 2341416, 2341420 |
Product
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Reason for recall
Unable to pass catheter through outer sheath during embryo transfer
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.