Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales
Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a non-sterile component being sold as a stand-alone item, which presents a theoretical risk of infection or improper use, but the source text does not report any specific illnesses, injuries, or hospitalizations.
Plain-English summary
Gyrus Medical, Inc. is recalling 507 units of the Gyrus ACMI Falope-Ring Dilator (item 000878-4). This conical plastic device is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30) and is intended to assist in the placement of the Falope-Ring band on a reusable applicator.
The recall is being conducted because the dilator, which is a non-sterile component, has been sold as a stand-alone item. The device is catalog number 000878-4 and is not lot controlled.
The affected units were distributed worldwide, including nationwide distribution in the United States across multiple states and in Canada. Consumers and healthcare providers should stop using the recalled dilator and contact Gyrus Medical for further instructions.
The recalled product
- Product
- Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists…
- Manufacturer
- Gyrus Medical, Inc
- Affected units
- 507
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 (2)
- catalog No.: 000878-4
- not lot controlled.
Distribution
Related recalls
Same manufacturer · Gyrus Medical, Inc
See all →- ModerateGyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects
FDA (Devices) · 2014-10-29
- ModerateGyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits
FDA (Devices) · 2014-03-19
- ModerateGyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
FDA (Devices) · 2013-08-28
Same hazard · non sterile component
See all →- 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
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighMedline surgical procedure kits recalled for potential sterility defect
FDA (Devices) · 2023-08-09
- HighMedical procedural kits recalled due to sterility concerns with ultrasound gel
FDA (Devices) · 2023-08-09
Similar recalls
- ModerateGyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits
FDA (Devices) · 2014-03-19
- HighGyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise
FDA (Devices) · 2014-12-03
- ModerateGyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
FDA (Devices) · 2013-08-28
- HighGyrus Acmi Recalls Disposable Myringotomy Knives Due to Sterility Concerns
FDA (Devices) · 2013-06-12
- HighDePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices
FDA (Devices) · 2014-10-15
- HighGyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns
FDA (Devices) · 2015-06-17