Terumo Medical Corporation
Complete recall history across all FDA and CPSC categories — 18 total recalls
Terumo Medical Corporation 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 (18)
FDA medical device enforcement actions by Terumo Medical Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 26, 2019 | SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... | There is a potential for dislodgement of the tip from the outer diameter of t... | Class I |
| Apr 26, 2019 | Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSO... | There is a potential for dislodgement of the tip from the outer diameter of t... | Class I |
| Apr 26, 2019 | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... | There is a potential for dislodgement of the tip from the outer diameter of t... | Class I |
| Feb 8, 2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Needle, 30G x 1/2", Product Code NN3013R | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Needle, 18G x 1", Product Code NN1825R | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Needle, 23G x 1", Product Code NN2325R | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Feb 8, 2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 | There is a potential for a loss of package integrity that may compromise the ... | Class II |
| Sep 12, 2017 | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Prod... | The tucking depth feature of this catheter introducer is marginally outside t... | Class II |
| Mar 16, 2016 | PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNAC... | Terumo Medical is initiating this recall due to complaints of valve leakage t... | Class II |
| Nov 6, 2015 | Destination Renal Guiding Sheath Intended for the introduction of interven... | Based on internal investigation and testing that revealed the distal end of c... | Class II |
| Aug 5, 2015 | SurFlo IV Catheter | According to the Terumo (TMC) this device is used to access the human periphe... | Class II |
| May 30, 2013 | Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Use... | Medical devices were incorrectly labeled with extended expiration dates. | Class II |
| May 30, 2013 | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Ti... | Medical devices were incorrectly labeled with extended expiration dates. | 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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