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 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.