Specialty Appliance Works, Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Specialty Appliance Works, 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 (10)
FDA medical device enforcement actions by Specialty Appliance Works, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 9, 2015 | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Compon... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance ... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/p... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 2... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is us... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A H... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21,... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | Class II |
| Mar 9, 2015 | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC ... | The Universal Nut, a component of the orthodontic Herbst Appliance was made w... | 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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