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.

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DateProductReasonClassFirm
Jul 20, 2021 Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent meas... If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dr... Class II Welch Allyn Inc
Jul 20, 2021 Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12... Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
Jul 20, 2021 Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens wi... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable C... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Con... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposabl... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens ... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact L... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Le... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 18, 2021 The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2021 Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Materia... Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated... Class II Siemens Healthcare Diagnostics, Inc.
May 3, 2021 VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemi... Ortho investigated and confirmed the potential for unexpected failed calibration, and condition c... Class II Ortho-Clinical Diagnostics, INc.
Apr 29, 2021 Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Co... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Tr... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Tra... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Trans... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cove... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cove... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-08... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Hays Ultrasound kit Item ID: H1000SE No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 27, 2021 The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) c... The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... Class II Circulatory Technology Inc.
Apr 22, 2021 ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount m... Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... Class II Welch Allyn Inc
Apr 22, 2021 GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall ... Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... Class II Welch Allyn Inc
Mar 26, 2021 INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
Mar 26, 2021 VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black R... Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly l... Class II Ortho-Clinical Diagnostics, INc.
Mar 26, 2021 KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibi... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
Mar 19, 2021 Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the cont... Potentially defective component in the AC power adapter which may fail over time. Class II Baxter Healthcare Corporation
Mar 17, 2021 Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: ... Positive Control may run high out of its assigned ISR range and result in an invalid run and nece... Class II Clark Laboratories, Inc.
Mar 5, 2021 ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematolog... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, Inc.
Mar 5, 2021 ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology a... Potential Sample Identification (SID) Mismatch with14-Character Barcodes Class II Siemens Healthcare Diagnostics, 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.