Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters
Smiths Medical ASD, Inc. is recalling 800 Wallace Sure-Pro Single Stage Embryo Replacement Catheters because the catheter cannot be passed through the outer sheath during embryo transfer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that prevents the completion of a medical procedure (embryo transfer). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the failure prevents the intended medical outcome but does not explicitly report physical injury or death.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 800 units of Wallace Sure-Pro Single Stage Embryo Replacement Catheters (Product Code: PP623). The recall is due to a defect where the catheter is unable to pass through the outer sheath during an embryo transfer procedure.
These catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. The affected products were distributed worldwide, including the United States and numerous international locations. The specific lot codes involved in this recall are 2000098, 2025748, 2041152, 2332539, and 2350024.
Clinicians and patients should stop using these specific catheters and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot codes: 2000098 2025748 2041152 2332539 2350024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighSmiths Medical Recalls ProtectIV Plus Safety IV Catheters
FDA (Devices) · 2019-11-20
- HighSmiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles
FDA (Devices) · 2015-01-07
- HighSmiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects
FDA (Devices) · 2016-12-28
- LowCooperSurgical Recalls Wallace Catheters Due to Expiration Date Error
FDA (Devices) · 2020-04-22
- CriticalSmiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
FDA (Devices) · 2019-02-13
- HighSmiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure
FDA (Devices) · 2015-01-07