Agency classClass IIOur severity:High FDA (Devices)·Z-1687-2024·Announced 2024-05-01

Water bottles used in dental treatment devices recalled for disassembly risk

Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure during treatment or storage. No injuries have been reported.

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: This is a Class II medical device recall for a pressurized component with a structural defect capable of causing device malfunction. The hazard is a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Electro Medical Systems SA is recalling water bottles (Model EG-121) used with AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE dental devices. These empty bottles are filled by users with water for dental treatments and become pressurized during use.

Some bottles assembled with certain bottle collars can disassemble into two parts when exposed to pressure—either during active treatment or during storage if the internal pressure is not released. This structural failure can result in loss of pressurization and device malfunction.

Approximately 462 units were affected and distributed worldwide, including to the United States (Illinois and Texas) and numerous countries internationally. Affected units are identified by specific lot numbers and serial numbers listed in the recall notice.

Consumers and healthcare providers should discontinue use of affected bottles and check serial numbers and lot codes to determine if their products are affected. Contact the manufacturer for more information.

The recalled product

Product: Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use.…
Manufacturer: Electro Medical Systems SA
Category: Medical Device — Dental / Therapeutic Equipment
Hazard: disassembly
pressure-loss
Affected units: 462

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 (11)

Lot Code: Model number: EG-121
UDI: 07613353180287 Lot number: 16457-10
Expiry date: 2026-04 Model number: EG-121
UDI: 07613353180287 Lot number: 16457-80
UDI: 07613353180287 Lot number: 16457-120
Expiry date: 2026-07 Model number: EG-121
UDI: 07613353180287 Lot number: 16457-130
Expiry date: 2026-10 Model number: EG-121
UDI: 07613353180287 Lot number: 16457-140
UDI: 07613353180287 Lot number: 16866-80
Expiry date: 2026-10: batch not impacted by the deviation

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Electro Medical Systems SA 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 3 products in this recall →

Same manufacturer · Electro Medical Systems SA

See all →

High
PIEZON Bottle May Disassemble Under Pressure During Dental Use
FDA (Devices) · 2024-05-01
High
Cleaner Bottles May Disassemble Under Pressure During Treatment
FDA (Devices) · 2024-05-01

Same hazard · disassembly