Acclarent, Inc.
Complete recall history across all FDA and CPSC categories — 13 total recalls
Acclarent, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (13)
FDA medical device enforcement actions by Acclarent, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 21, 2023 | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ... | When using affected curette and software, there is a discrepancy between the ... | Class II |
| Nov 12, 2021 | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS0... | Suction Instruments were incorrectly calibrated so they may not meet the syst... | Class II |
| Mar 6, 2019 | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | The firm became aware that three (3) lots of the NAV Suction Instruments con... | Class II |
| Mar 6, 2019 | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | The firm became aware that three (3) lots of the NAV Suction Instruments con... | Class II |
| Mar 6, 2019 | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | The firm became aware that three (3) lots of the NAV Suction Instruments con... | Class II |
| Apr 28, 2015 | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U... | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was di... | Class III |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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