Onkos Surgical, Inc.
Complete recall history across all FDA and CPSC categories — 16 total recalls
Onkos Surgical, 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 (16)
FDA medical device enforcement actions by Onkos Surgical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal f... | Unidentified substance of unknown impact was identified on devices during a r... | Class II |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAI... | Unidentified substance of unknown impact was identified on devices during a r... | Class II |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED,... | Unidentified substance of unknown impact was identified on devices during a r... | Class II |
| May 20, 2025 | My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It... | Required inspections were not performed on finished product prior to release ... | Class II |
| Sep 22, 2024 | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL... | Potential challenge with intraoperative assembly of the external taper of a s... | Class II |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which inclu... | Class II |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which inclu... | Class II |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... | Potential for breach of Tyvek seals. | Class II |
| Sep 1, 2023 | Male-Female Midsection with the following sizes and model numbers. a. Male... | Potential for breach of Tyvek seals. | Class II |
| Sep 1, 2023 | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... | Potential for breach of Tyvek seals. | Class II |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... | Potential for breach of Tyvek seals. | Class II |
| Sep 1, 2023 | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... | Potential for breach of Tyvek seals. | Class II |
| Sep 1, 2023 | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... | Potential for breach of Tyvek seals. | Class II |
| May 23, 2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... | The device collar size was incorrectly labeled as 25 mm where it should be re... | Class II |
| May 23, 2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGT... | The device collar size was incorrectly labeled as 25 mm where it should be re... | Class II |
| May 23, 2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... | The device collar size was incorrectly labeled as 25 mm where it should be re... | 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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