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
Nov 3, 2017 NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... Contact lenses lack sterility assurance. Class II Alden Optical
Oct 17, 2017 Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL... Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 17, 2017 BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 a... The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (c... Class II Siemens Healthcare Diagnostics
Oct 6, 2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI... Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu... Class II Baxter Healthcare Corporation
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individu... The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... Class II Circulatory Technology Inc
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary ... The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... Class II Circulatory Technology Inc
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c... Product was placed into distribution prior to completion of all required post sterilization relea... Class II Angiodynamics, Inc.
Sep 1, 2017 Respire Pink+ Hard Oral Sleep Apnea Device Potential for device breakage during use Class II Respire Medical
Sep 1, 2017 Respire Pink+ Hard/Soft Oral Sleep Apnea Device Potential for device breakage during use Class II Respire Medical
Sep 1, 2017 Respire Pink H/S Oral Sleep Apnea Device Potential for device breakage during use Class II Respire Medical
Sep 1, 2017 Respire Pink H/S Oral Sleep Apnea Device Potential for device breakage during use Class II Respire Medical
Sep 1, 2017 Respire Pink Series EF+ Oral Sleep Apnea Device. Potential for device breakage during use Class II Respire Medical
Sep 1, 2017 Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com... The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la... Class III CooperVision Inc.
Aug 31, 2017 LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrica... A shipment of LCSU 4 suction units and canisters attempted importation into the United States but... Class II Laerdal Medical Corporation
Aug 3, 2017 Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Jul 7, 2017 Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery... The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective ... Class II Ondamed Inc
Jun 29, 2017 Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Si... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: S... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siem... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K201... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Sieme... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/104643... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative dete... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 27, 2017 Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspi... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # ... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Us... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...

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.