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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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... |
| Jun 19, 2017 | STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | Class II | ConMed Corporation |
| Jun 19, 2017 | STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | Class II | ConMed Corporation |
| Jun 12, 2017 | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Or... | The firm identified the potential for biased results to be generated when processing VITROS PHYT ... | Class II | Ortho-Clinical Diagnostics |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 1, 2017 | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usa... | Intact carton revealed presence of shredded burn sheets | Class II | Dukal Corp. |
| May 25, 2017 | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all othe... | Carestream found a single unit where four screws in the assembly were not applied in the manufact... | Class II | Carestream Health Inc |
| Apr 26, 2017 | enGen Track System with TCAutomation Software Version 4.2 | A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... | Class II | Ortho-Clinical Diagnostics |
| Apr 17, 2017 | Nonabsorbable suture anchor system intended to reattach soft tissue to bone i... | Manufactured with the incorrect anchor outer body | Class II | ConMed Corporation |
| Apr 3, 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following siz... | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff i... | Class II | Intersurgical Inc |
| Mar 13, 2017 | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-... | SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under t... | Class II | Valeant Pharmacueticals International |
| Mar 8, 2017 | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... | Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... | Class II | Ortho-Clinical Diagnostics |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT C... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E757... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PROD... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
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.