Ormco/Sybronendo
Complete recall history across all FDA and CPSC categories — 16 total recalls
Ormco/Sybronendo 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 (16)
FDA medical device enforcement actions by Ormco/Sybronendo
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 17, 2020 | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot... | The action is being taken due to an increase in complaints relating to the lo... | Class II |
| Jan 17, 2020 | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot... | The action is being taken due to an increase in complaints relating to the lo... | Class II |
| Jan 14, 2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... | The bracket torque was mislabeled on the packaging. | Class II |
| Dec 27, 2017 | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers ... | Buchanan Heat Pluggers will possibly overheat while used with the Elements Ob... | Class II |
| Aug 31, 2016 | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex X... | SybronEndo is recalling the Sealapex Xpress because it was labeled with an in... | Class II |
| Feb 8, 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50... | Class II |
| Nov 4, 2015 | Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N... | Ormco Corporation is recalling Copper NiTi Preformed Archwires because the pr... | Class II |
| Mar 25, 2014 | Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 4... | Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Par... | Class II |
| Mar 25, 2014 | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number ... | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 49... | Class II |
| Jul 12, 2013 | Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. ... | Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws ... | Class II |
| Mar 8, 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tube... | Class II |
| Jan 17, 2013 | SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... | A recall has been issued by SybronEndo because a Canadian Standards Associati... | Class II |
| Jan 17, 2013 | SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... | A recall has been issued by SybronEndo because a Canadian Standards Associati... | Class II |
| Dec 12, 2012 | Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 2... | The length markings on the Lightspeed LSX files were wrong. | Class II |
| Apr 24, 2012 | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... | The firm initiated the recall as a result of a misidentification of the brack... | Class III |
| Dec 12, 2011 | Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. | The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreig... | 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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