Browse Device Recalls
1,382 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,382 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,382 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2018 | Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 18, 2018 | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 | If an operator attempts to manually program a Basic Infusion for a drug that is not included in t... | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1... | Foreign material in product | Class II | CMP Industries, Llc |
| Sep 12, 2018 | IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml... | Foreign material in product | Class II | CMP Industries, Llc |
| Aug 29, 2018 | Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compres... | The product was designed for 120V usage and is being used in South Africa with 220V. There is a ... | Class II | SANRAI INTERNATIONAL LLC |
| Aug 28, 2018 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... | The reagent pack exhibits the potential for an increased frequency of calibration failures. | Class II | Ortho-Clinical Diagnostics |
| Aug 24, 2018 | Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Life Technologies, Corp. |
| Aug 24, 2018 | Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Life Technologies, Corp. |
| Aug 24, 2018 | Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Life Technologies, Corp. |
| Aug 24, 2018 | Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vi... | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Life Technologies, Corp. |
| Aug 15, 2018 | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quan... | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... | Class II | Ortho-Clinical Diagnostics |
| Aug 15, 2018 | VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quanti... | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... | Class II | Ortho-Clinical Diagnostics |
| Aug 14, 2018 | APTIO CENTRIFUGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 9000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO RACK OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 15000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 9000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO INPUT/OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB CORE UNIT / LYNX WITH IOM | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO RACK INPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 15000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 24, 2018 | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL... | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual ste... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... | The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 3, 2018 | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jul 3, 2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jun 29, 2018 | Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 21, 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), pro... | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pum... | Class II | Baxter Healthcare Corporation |
| May 29, 2018 | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope | Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-... | Class II | Zeiss, Carl Inc |
| May 10, 2018 | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M161567 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalo... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL XPP, Catalog Number 60M030393 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wir... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL XCELA PICC, Catalog Number 60M122272 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.