The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1188-2018·Announced 2018-04-04

Cook Inc. Recalls IVF Embryo Transfer Sets Due to Quality Testing Gaps

Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.

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 where the hazard is a risk of harm (nonviable embryos) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 473 units of specific in vitro fertilization (IVF) products, including the SMS Embryo Transfer Set, Guardia Access Nano Embryo Transfer Catheter, and Sydney IVF Embryo Transfer Set. The recall affects specific catalog numbers and lot numbers with expiration dates ranging from November 2018 to March 2019.

The recall was initiated because these products were distributed without completed finished device quality testing. The FDA notes that this lack of testing creates a potential for adverse events, specifically the use of nonviable gametes and/or nonviable embryos.

The affected products were distributed worldwide, including in the United States (CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI) and in 13 other countries. Consumers and healthcare providers should stop using these specific lots and contact Cook Inc. for further instructions or replacement.

The recalled product

Product
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF…
Manufacturer
Cook Inc.
Category
Medical Device — IVF / Reproductive
Hazard
Affected units
473

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 (9)

  • 1. Catalog Number: K-J-SMS-571800
  • Lot Number: 6802704
  • Expiration Date: 3/10/2019
  • 2. Catalog Number: K-JETS-551910-L
  • Lot Number: NS6360603
  • Expiration Date: 11/15/2018
  • 3. Catalog Number: K-JETS-7019-SIVF
  • Lot Number: 6503675
  • Expiration Date: 2/2/2019

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Cook 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 4 products in this recall →

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