Browse Device Recalls
1,398 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,398 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 1,398 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2020 | Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydro... | Incorrect power of lenses than the expected | Class II | CooperVision Inc. |
| Jan 12, 2020 | Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 | Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diag... | Carestream Health has discovered a potential safety problem that can lead to unintended movement ... | Class II | Carestream Health, Inc. |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 31, 2019 | Koios DS Breast <series 1.0>. The device is a software application which assi... | Affected software product versions were found during internal audit to have been marketed for sal... | Class II | Koios Medical, Inc. |
| Dec 20, 2019 | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ... | Firm has received customer complaints regarding failed calibrations and increased imprecision of ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2019 | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 | There is a potential for falsely depressed creatinine results for patients on phenindione therapy... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2019 | Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 | There is a potential for falsely depressed creatinine results for patients on phenindione therapy... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2019 | Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 | There is a potential for falsely depressed creatinine results for patients on phenindione therapy... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2019 | Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 | There is a potential for falsely depressed creatinine results for patients on phenindione therapy... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 19, 2019 | MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us... | May result in readings outside of the expected accuracy range. | Class II | Angiodynamics, Inc. |
| Nov 19, 2019 | Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ... | Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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 |
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.