CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report

Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter recalled

Smiths Medical ASD is recalling Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet, distributed nationwide in the US. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960

Quantity recalled11550 units

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-1241-2013
FDA event ID: 64705
Recalling firm: Smiths Medical ASD, Keene, NH
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2013
FDA classified: 3 May 2013
Reported: 15 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

28 Mar 2013	Recall initiated by company
3 May 2013	Classified by FDA	+36 days
15 May 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unable to pass catheter through outer sheath during embryo transfer

Product as listed by the FDA

Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 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.

Where it was distributed

Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).

Nationwide Arkansas California Colorado Illinois

Questions about this recall

Why was it recalled?

Unable to pass catheter through outer sheath during embryo transfer

Which lots are affected?

Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 64705

This product is part of a recall event; the main page for the event is Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter recalled.

Reported	Class	Recall	Company	Reason	Where
15 May 2013	CLASS II	Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter recalled	Smiths Medical ASD	Other	Nationwide
15 May 2013	CLASS II	Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter recalled	Smiths Medical ASD	Other	Nationwide
15 May 2013	CLASS II	Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement recalled	Smiths Medical ASD	Other	Nationwide
15 May 2013	CLASS II	Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product recalled	Smiths Medical ASD	Other	Nationwide
15 May 2013	CLASS II	Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter recalled	Smiths Medical ASD	Other	Nationwide

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