OriGen Biomedical, Inc.
Complete recall history across all FDA and CPSC categories — 19 total recalls
OriGen Biomedical, 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 (19)
FDA medical device enforcement actions by OriGen Biomedical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 19, 2023 | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... | Accessory sets contain a syringes not yet qualified for the accessory's inten... | Class II |
| Jan 28, 2021 | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... | It was identified that tissue culture bags were incorrectly labeled as free... | Class III |
| Jun 24, 2019 | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile E... | The firm has become aware that they have distributed product that was expired. | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications:... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 21, 2018 | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indicati... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... | The catheter failed the endotoxin testing. | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: ... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: ... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 21, 2018 | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications:... | These catheters may have the following deficiencies: 1) barium sulfate omissi... | Class II |
| Aug 2, 2017 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen E... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | Clamping the clear tube very close to the blue hub may cause a localized adhe... | Class I |
| Mar 30, 2015 | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO... | Potential for clear extension tube to separate from the hub, which could resu... | Class I |
| Mar 30, 2015 | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO... | Potential for clear extension tube to separate from the hub, which could resu... | Class I |
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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