CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error
CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date.
Plain-English summary
CooperSurgical, Inc. is recalling Wallace Artificial Insemination Catheters, 180 mm, Sterile, Model AIC18JP. The recall is due to an expiration date discrepancy where the product was marked with a 5-year expiration date, but the correct expiration date is 3 years.
The affected product is Lot number 250887. The distribution was limited to Japan only. The intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
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 number 250887
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- HighCooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2014-06-18
- LowCooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert
FDA (Devices) · 2016-09-28
- LowCooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
FDA (Devices) · 2014-11-19
- HighSmiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters
FDA (Devices) · 2013-05-15
- ModerateHydroPICC Catheters Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2023-02-22
- ModerateCooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error
FDA (Devices) · 2015-07-29