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 |
|---|---|---|---|---|
| Nov 19, 2019 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calib... | Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-D... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 19, 2019 | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Numbe... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Oct 11, 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 2, 2019 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | When the user tilts the transmitted light arm of the microscope to the end of its axis range, las... | Class II | Zeiss, Carl Inc |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may experience a proced... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 23, 2019 | Atellica CH 930 Analyzer | Potential for calibration error resulting in QC failures after the calibration run with QC and pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 10, 2019 | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Uri... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Sep 10, 2019 | VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which c... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Sep 10, 2019 | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT sup... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Aug 20, 2019 | 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product... | Mislabeled needle lengths | Class II | Repro-Med Systems, Inc. |
| Aug 15, 2019 | Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Materia... | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2019 | Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material... | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 1, 2019 | LightPod Neo Lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ... | Class II | Aerolase Corporation |
| Aug 1, 2019 | LightPod ERA lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ... | Class II | Aerolase Corporation |
| Jul 30, 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2K... | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 350 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 4600 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250AT Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5,1 FS Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jun 27, 2019 | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... | Class II | Angiodynamics, Inc. |
| Jun 27, 2019 | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de... | Iincreased (falsely elevated) Albumin results compared to expected results | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... | Class II | Epimed International, Inc. |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... | Class II | Epimed International, Inc. |
| Jun 17, 2019 | VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem... | Potentially Biased Results using VITROS Chemistry Products GLU Slides | Class II | Ortho-Clinical Diagnostics |
| Jun 11, 2019 | CTSTM Essential 8 Medium | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Jun 11, 2019 | StemPro¿ MSC SFM CTS" | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | 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.