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Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 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 1,361 FDA device recalls in NY.

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DateProductReasonClassFirm
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.)
May 10, 2018 RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 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 MIDLINE, Catalog Number 60M035472 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 60M183481 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 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 MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Nu... 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 KIT, Catalog Number 60M183104 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 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 Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numb... 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 DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidew... 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 PICC, Catalog Number 60M071831 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 60M181578 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 IR-145 Kit Non-Valved PG, Catalog Number 45-872 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 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 60M150373 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 XCELA PICC PASV, Catalog Number 60M181582 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.

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.