Stryker Leibinger GmbH & Co. KG
Complete recall history across all FDA and CPSC categories — 25 total recalls
Stryker Leibinger GmbH & Co. KG 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 (25)
FDA medical device enforcement actions by Stryker Leibinger GmbH & Co. KG
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 4, 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... | Unreleased software was installed on customer systems resulting in the visual... | Class II |
| Mar 29, 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314... | Class II |
| Dec 6, 2022 | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | Device was shipped without having regulatory approval. | Class II |
| Dec 29, 2021 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Inside the packaging of one reported item a non-conforming product was found.... | Class II |
| Apr 1, 2021 | DirectInject consists of a sterile dual paste system which is calcium phospha... | Inability for the user to inject the paste from the syringe into the target ... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Num... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING ... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Nu... | After a three year term, there is a potential for the external packaging (ste... | Class II |
| Jan 3, 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... | An incorrect sterility status on the label, non-sterile products labeled as s... | Class II |
| Jan 3, 2017 | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... | An incorrect sterility status on the label, non-sterile products labeled as s... | 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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