Severity
Moderate
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a compone
Reported: September 3, 2025 Initiated: July 24, 2025 #Z-2422-2025 780 units units
Dentsply IH, Inc. issued this FDA Devices recall on September 3, 2025. Classified as Moderate severity (Class II). Approximately 780 units units are affected. The recall was issued because: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2422-2025) was formally reported on September 3, 2025, with the manufacturer initiating the action on July 24, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Dentsply IH, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records indicate 780 units units are affected.
The documented reason for this recall is: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to ful… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
780 units
Related Recalls
6
6 from same agency
Product Description
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
Reason for Recall
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Details
- Recalling Firm
- Dentsply IH, Inc.
- Units Affected
- 780 units
- Distribution
- Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.
- Location
- Waltham, MA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2422-2025 |
| Date reported | September 3, 2025 |
| Date initiated | July 24, 2025 |
| Recalling firm | Dentsply IH, Inc. |
| Units affected | 780 units |
| Distribution | Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component. Recalled by Dentsply IH, Inc.. Units affected: 780 units.
Why was this product recalled? ▼
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2422-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2422-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).