Class IIOngoingZ-2309-2026
SSC- Surgical Specialties Corporation recalls Sharpoint 2.2MM
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
- Ophthalmic Knife
- Mixed-up of materials/components
SSC- Surgical Specialt…CAJun 10, 2026
Mixed-up of materials/components
An FDA-recorded root-cause determination. The FDA lists 10 recalls with this root cause since 2025. Most recent report: Jun 10, 2026.
Class II: 10
Latest recalls
View all 10 in the recall browser →Class IIOngoingZ-2200-2026
MICROVENTION INC. recalls LVIS Intraluminal Support Device
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration.…
- Intracranial Coil-Assist Stent
- Mixed-up of materials/components
MICROVENTION INC.CAMay 20, 2026
Class IIOngoingZ-2474-2025
Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits a…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Heparin Assay
- Mixed-up of materials/components
Diagnostica Stago, Inc…NJSep 3, 2025
Class IIOngoingZ-2473-2025
Diagnostica Stago, Inc. recalls STA Satellite. Product Code: All references. All software versions. The STA Satellit…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Multipurpose For In Vitro Coagulation Studies System
- Mixed-up of materials/components
Diagnostica Stago, Inc…NJSep 3, 2025
Class IIOngoingZ-2475-2025
Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Heparin Assay
- Mixed-up of materials/components
Diagnostica Stago, Inc…NJSep 3, 2025
Class IIOngoingZ-2476-2025
Diagnostica Stago, Inc. recalls STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is inte…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Fibrinogen Determination System
- Mixed-up of materials/components
Diagnostica Stago, Inc…NJSep 3, 2025
Class IIOngoingZ-1957-2025
Microbiologics Inc recalls KWIK-STICK
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs.…
- Quality Control For Culture Media Kit
- Mixed-up of materials/components
Microbiologics IncMNJun 18, 2025
Class IITerminatedZ-1754-2025
Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
- Dual-Balloon Transluminal Peripheral Angioplasty Catheter
- Mixed-up of materials/components
Numed IncNYMay 21, 2025
Class IIOngoingZ-1650-2025
Medtronic MiniMed, Inc. recalls InPen smart insulin pen
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder;…
- Piston Syringe
- Mixed-up of materials/components
Medtronic MiniMed, Inc…CAApr 30, 2025
Class IIOngoingZ-1504-2025
Qiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Numb…
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Mixed-up of materials/components
Qiagen Sciences LLCMDApr 9, 2025
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.