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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Electro Medical Systems SA: Dental Cleaning and Water Bottles Recalled Due to Pressurized Detachment Risk

Agency Publication Date: April 24, 2024
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Summary

Approximately 858 CLEANER, WATER, and PIEZON bottles used with EMS AIRFLOW PROPHYLAXIS dental devices are being recalled because the bottle collars can fail while under pressure. If the collar fails, the bottle can disassemble into two parts during dental treatment or storage, potentially causing the pressurized bottle to detach unexpectedly. These bottles were distributed in Illinois, Texas, and worldwide for use with AIRFLOW PROPHYLAXIS MASTER and ONE devices.

Risk

The bottle collars can fail and allow the assembly to break apart when the bottle is pressurized during dental procedures or storage. This poses a risk of impact or injury to patients or dental staff if the bottle components are forcefully ejected while under pressure.

What You Should Do

  1. Check your dental equipment for CLEANER bottles (Model EG-1000), WATER bottles (Model EG-121), and PIEZON bottles (Model EG-111).
  2. For CLEANER bottles, identify Lot 16442-210 with an expiration date of April 2026. This is used with devices having UDI-DI codes 07613353213183, 07613353184148, or 07613353184124.
  3. For WATER bottles, check for Lot numbers 16457-10, 16457-80, 16457-120, 16457-130, 16457-140, or 16866-80, all with expiration dates in April, July, or October 2026.
  4. For PIEZON bottles, check for Lot numbers 16442-190 (Exp 2026-04) and 16694-30 (Exp 2026-07).
  5. Verify the serial number of your bottle against the extensive list of affected units, which includes serials starting with prefixes KU, LD, and LG.
  6. Contact your healthcare provider or Electro Medical Systems SA directly to discuss replacement components and to receive further instructions on how to safely handle the affected bottles.
  7. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall following complaints

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CLEANER BOTTLE
Model / REF:
EG-1000
EG-1000A x1
UPC Codes:
07613353180225
07613353213183
07613353184148
07613353184124
Lot Numbers (342):
16442-210
KU23665
KU23668
KU23669
KU23670
KU23671
KU23673
KU23674
KU23675
KU23676
KU23677
KU23679
KU23680
KU23681
KU23682
KU23683
KU23684
KU23685
KU23687
KU23690
KU23691
KU23692
KU23693
KU23694
KU23695
KU23696
KU23697
KU23698
KU23699
KU23702
KU23704
KU23705
KU23707
KU23708
KU23709
KU23710
KU23711
KU23712
KU23713
KU23714
KU23715
KU23717
KU23718
KU23720
KU23721
KU23723
KU23724
LD05012
LD05033
LD05034
Date Ranges: Expiry date: 2026-04
Product: WATER BOTTLE
Model / REF:
EG-121
UPC Codes:
07613353180287
07613353213183
07613353184148
07613353184124
Lot Numbers (415):
16457-10 (Exp 2026-04)
16457-80 (Exp 2026-04)
16457-120 (Exp 2026-07)
16457-130 (Exp 2026-10)
16457-140 (Exp 2026-10)
16866-80 (Exp 2026-10)
LD04753
LD04757
LG10166
LG10167
LG10168
LG10169
LG10170
LG10171
LG10172
LG10173
LG10174
LG10175
LG10151
LG10152
LG10153
LG10154
LG10155
LG10156
LG10157
LG10158
LG10159
LG10160
LG10161
LG10162
LG10163
LG10164
LG10165
LG10413
LG10414
LG10416
LG10418
LG10421
LG11050
LG11051
LG11052
LG11053
LG11054
LG11055
LG11056
LG11057
LG11127
LG11128
LG11129
LG11130
Date Ranges: April 2026, July 2026, October 2026
Product: PIEZON Bottle
Model / REF:
EG-111
UPC Codes:
07613353180249
07613353213183
07613353184148
07613353184124
Lot Numbers (56):
16442-190 (Exp 2026-04)
16694-30 (Exp 2026-07)
KU23667
KU23689
KU23700
KU23701
KU23703
KU23722
KU24328
KU24330
KU24331
KU24333
KU24334
KU24335
KU24337
KU24339
KU24340
KU24341
KU23719
KU24336
KU24338
KU24342
KU24344
KU24346
KU24349
KU24354
KU24356
KU23666
KU23672
KU23678
KU23686
KU23688
KU23706
KU23716
KU24343
KU24345
KU24347
KU24348
KU24350
KU24351
KU24353
KU24355
KU24357
KU24363
KU24366
KU24367
KU24368
KU24369
KU24370
KU24371
Date Ranges: April 2026, July 2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94293
Status: Active
Manufacturer: Electro Medical Systems SA
Sold By: Authorized EMS Dental distributors; Specialty dental suppliers
Manufactured In: Switzerland
Units Affected: 3 products (342; 462; 54)
Distributed To: Illinois, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.