Integra Limited
Complete recall history across all FDA and CPSC categories — 9 total recalls
Integra Limited 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 (9)
FDA medical device enforcement actions by Integra Limited
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 31, 2019 | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra ... | Stability did not meet acceptance criteria for visual appearance during mixin... | Class II |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - ... | Temperature indicator may have changed color to dark gray or black prior to s... | Class II |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - ... | Temperature indicator may have changed color to dark gray or black prior to s... | Class II |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - P... | Temperature indicator may have changed color to dark gray or black prior to s... | Class II |
| Sep 10, 2013 | Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca... | Integra LifeSciences has identified through an internal evaluation that in or... | Class II |
| Jul 17, 2013 | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hard... | As a result of complaint investigations it was identified that there is a pot... | Class II |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... | An investigation of customer complaints identified that for two product lots,... | Class II |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... | An investigation of customer complaints identified that for two product lots,... | Class II |
| May 23, 2012 | Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(... | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were relea... | 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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