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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94293

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 13, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Electro Medical Systems SA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

Z-1686-2024
Recall number
Z-1686-2024
Initiated
March 13, 2024
Classification
Class II
Status
Ongoing
Quantity
342

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Code information

Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: 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 LD05035 LD05036 LD05037 LD05100 LD05101 LD05102 LD05103 LD05104 LD05105 LD05106 LD05107 LD05108 LD05109 LD05110 LD05111 LD05112 LD05113 LD05114 LD05115 KU23666 KU23667 KU23672 KU23678 KU23686 KU23688 KU23689 KU23700 KU23701 KU23703 KU23706 KU23722 KU24328 KU24341 KU23716 KU23719 KU24342 KU24343 KU24344 KU24345 KU24346 KU24347 KU24348 KU24349 KU24350 KU24351 LD05116 LD05117 LD05118 LD05119 LD05120 LD05121 LD05122 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 KU21778 KU21884 KU21915 KU21948 KU21972 KU22135 KU22136 KU22137 KU22138 KU22139 KU22140 KU22141 KU22142 KU22143 KU22146 KU22147 KU22165 KU22166 KU22167 KU22168 KU22169 KU22170 KU22171 KU22172 KU22173 KU22174 KU22175 KU22176 KU22177 KU22178 LD05038 LD05039 LD05041 LD05042 KU21767 KU21990 KU21991 KU22592 KU23365 KU23366 KU23367 KU23368 KU23369 KU23370 KU23371 KU23372 KU23373 KU23374 KU23375 KU23376 KU23378 KU23379 KU23381 KU23382 LD05093 LD05536 LD05094 LD05095 LD05096 KU23023 KU23026 KU23027 KU23029 KU23030 KU23031 KU23032 KU23064 KU23112 KU23119 KU23120 KU23123 KU23128 KU23131 KU23132 KU23252 KU23263 KU23264 KU23265 KU23266 KU23267 KU23268 KU23269 KU23270 KU23271 KU23272 KU23273 KU23275 KU23276 KU23277 KU23278 KU23279 KU23280 KU23281 KU23282 KU23283 KU23284 KU23289 KU23294 KU23305 LD05537 LD05097 LD05098 LD05099 LD05538 LD05539 LD05540 LD05541 LD05542 KU25788 KU25789 KU25790 KU25791 KU25792 KU25793 KU25794 KU25795 KU25796 KU25797 KU25798 KU25799 KU25800 KU25801 KU25802 KU25803 LD05607 LD05664 LD05665 LD05666 LD05667 LD05668 LD05669 LD05670 LD05671 LD05672 LD05673 LD05674 LD05675 LD05676 LD05677 LD05678 KU25758 KU25759 KU25760 KU25761 KU25762 KU25763 KU25764 KU25765 KU25766 KU25767 KU25768 KU25769 KU25770 KU25771 KU25772 KU25773 LD05679 LD05680 LD05681 LD05682 LD05683 LD05684 LD05685 LD05686 LD05687 KU26136 KU26140 KU26141 KU26142 KU26143 KU26144 KU26145 KU26146 KU26155 KU26846 KU26968 KU26969 KU26970 KU26971 KU26972 KU26973 KU26974 KU26975 KU26976 KU26977 KU26978 KU26979 KU26980 KU26981 KU26091 KU26094 KU26097 KU26168 LD05723 LD05724 LD05725 LD05726 LD05727 KU26205 KU26206 KU26218 KU26219 KU26220 KU26221 KU26222 KU26223 KU26224 KU26225 KU26226 KU26227 KU26228 KU26229 KU26230 KU26231 KU26281 KU26284 KU26285 KU26289 EG-1000A x1 OF-99-12848-1

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.

device · product 2 of 3

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. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

Z-1687-2024
Recall number
Z-1687-2024
Initiated
March 13, 2024
Classification
Class II
Status
Ongoing
Quantity
462

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Code information

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, Expiry date: 2026-04 Model number: EG-121, 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, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16866-80, Expiry date: 2026-10: batch not impacted by the deviation, but as the expiry date is the same than other batches impacted it was decided to recall this batch as well because the expiry date is engraved on the bottles and the user might not be able to differentiate the batch number if the packaging was disposed of. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: 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 OF-04-05367-1 LG10413 LG10414 LG10416 LG10418 LG10421 LG11050 LG11051 LG11052 LG11053 LG11054 LG11055 LG11056 LG11057 LG11127 LG11128 LG11129 LG11130 LG11131 LG11132 LG11133 LG11134 LG11135 LG11136 LG11313 LG11314 LG11315 LG11316 LG11317 LG11318 LG11319 LG11320 LG11321 LG11322 LG11323 LG11324 LG11325 LG11326 LG11327 LG11328 LG11329 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05038 LD05039 LD05041 LD05042 LD04674 LD04913 LD04914 LD04915 LD04916 LD04917 LG10681 LG10682 LG10683 LG10684 LG10685 LG10686 LG10687 LG10690 LG10691 LG10692 LG10693 LG10694 LG10695 LG10696 LG10697 LG10698 LG10699 LG10700 LG10701 LG10702 LG10703 LG10704 LG10705 LG10706 LG10707 LG10908 LG10909 LG10910 LG10911 LG10912 LG10913 LG10914 LG10915 LG10916 LG10917 LG10918 LG10919 LG10920 LG10921 LG10929 LG10930 LG10931 LG10932 LG10933 LG10934 LG10935 LG10936 LG10937 LG10938 LG10939 LD04918 LD04919 LD04920 LD04921 LD04922 LD04923 LD04924 LD04925 LD04926 LD04927 LD04928 LD04930 LD04931 LD04932 LD04933 LD04934 LD04935 LD04936 LD04937 LD04938 LG10987 LG10988 LG10989 LG10990 LG10991 LG10992 LG10993 LG10994 LG10995 LG10996 LG10997 LG10998 LG10999 LG11000 LG11001 LG11002 LG11003 LG11004 LG11006 LG11005 LG11007 LG11008 LG11009 LG11010 LG11011 LG11013 LG11014 LG11015 LG11016 LG11017 LG11018 LG11019 LG11020 LG11021 LG11022 LG11023 LG11024 LG11025 LG11026 LG11027 LG11028 LG11029 LG11030 LG11031 LG11032 LG11033 LG11034 LG11035 LG11036 LG11037 LD05115 LD05120 LD05121 LD05122 LD05105 LD05107 LD05108 LD05110 LD05114 LD05093 LD05094 LD05095 LD05096 LD05097 LD05098 LD05099 LD05100 LD05102 LD05103 LD05104 LD04939 LD04940 LD04941 LD04942 LD05106 LD05111 LD05112 LD05113 LD05116 LD05117 LD05118 LD05119 LG12099 LG12098 LG12097 LG12096 LG12095 LG12094 LG12093 LG12092 LG12091 LG12090 LG12089 LG12088 LG12087 LG12086 LG12085 LG12084 LG12083 LG12082 LG12076 LG12075 LG12075 LG12076 LG12082 LG12083 LG12084 LG12085 LG12086 LG12087 LG12088 LG12089 LG12090 LG12091 LG12092 LG12093 LG12094 LG12095 LG12096 LG12097 LG12098 LG12099 LD05101 LD05109 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 LD05536 LD05537 LD05538 LD05539 LD05540 LD05541 LD05542 LD05101 LD05109 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 LD05536 LD05537 LD05538 LD05539 LD05540 LD05541 LD05542 LD05607 LD05664 LD05665 LD05666 LD05667 LD05668 LD05669 LD05670 LD05671 LD05672 LD05673 LD05674 LD05675 LD05676 LD05677 LD05678 LD05679 LD05680 LD05681 LD05682 LD05683 LD05684 LD05685 LD05686 LD05687 LG13419 LG13420 LG13421 LG13422 LG13423 LG13424 LG13425 LG13426 LG13427 LG13428 LD05723 LD05724 LD05725 LD05726 LD05727 LG13975 LG13976 OF-04-05473-1 LG11370 LG11369 LG11368 LG11367 LG11366 LG11365 LG11364 LG11363 LG11362 LG11361 LG11360 LG11359 LG11358 LG11357 LG11356 LG11352 LG11351 LG11350 LG11349 LG11348 LG11347 LG11346 LG11345 LG11344 LG11343 LG11342 LG11341 LG11340 LG11339 LG11338 LG11337 LG11336 LG11335 LG11329 LG11328 LG11327 LG11326 LG11325 LG11324 LG11323 LG11322 LG11321 LG11320 LG11319 LG11318 LG11317 LG11316 LG11315 LG11314 LG11313 LD05092 LD05091 LD05090 LD05089 LD05088 LD05087 LD05086 LD05085 LD05084 LD05083 LD05082 LD05081 LD05080 LD05079 LD05078 LD05077 LD05076 LD05075 LD05074 LD05073 LD05072 LD05071 LD05070 LD05069 LD05068 LD05067 LD05066 LD05065 LD05064 LD05063 LD04929

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.

device · product 3 of 3

Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

Z-1688-2024
Recall number
Z-1688-2024
Initiated
March 13, 2024
Classification
Class II
Status
Ongoing
Quantity
54

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Code information

Lot Code: Model number: EG-111, UDI: 07613353180249 Lot number: 16442-190, Expiry date: 2026-04 Model number: EG-111, UDI: 07613353180249 Lot number: 16694-30 Expiry date: 2026-07 AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: 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 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.