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 15, 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 9, 2016 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product C... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Produc... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 6464... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Oct 26, 2016 | VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per ... | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products ... | Class III | Ortho-Clinical Diagnostics |
| Oct 21, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens rec... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 7, 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration o... | Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class II | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 19, 2016 | PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. T... | Product was found to contain excess residual levels of hydrogen peroxide. | Class II | Bausch & Lomb Inc Irb |
| Sep 7, 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 7, 2016 | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Dis... | Mislabeling of the "expiration date". The expiration date on the outer box and the individual po... | Class II | Ellman International, Inc. |
| Sep 7, 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Therm... | Ortho confirmed that it is possible for the mis-association of sample identification and assay re... | Class II | Ortho-Clinical Diagnostics |
| Aug 30, 2016 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 29, 2016 | CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-02... | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could resul... | Class II | ConMed Corporation |
| Aug 29, 2016 | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 29, 2016 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 29, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 24, 2016 | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ... | Siemens received multiple customer complaints indicating an increase in false positive and indete... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 24, 2016 | SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ... | Siemens received multiple customer complaints indicating an increase in false positive and indete... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 11, 2016 | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Jul 20, 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA... | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 11, 2016 | Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: ... | Possible dull knife edge | Class II | Bausch & Lomb Inc Irb |
| Jul 11, 2016 | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 63... | After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away... | Class II | Ivoclar Vivadent, Inc. |
| Jul 11, 2016 | Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to... | Possible dull knife edge | Class II | Bausch & Lomb Inc Irb |
| Jul 11, 2016 | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ... | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator ... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Jul 8, 2016 | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE... | A software issue related to the generic volume measurement functionality could result in the volu... | Class II | Carestream Health Inc |
| Jul 1, 2016 | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressur... | Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. | Class III | Circulatory Technology Inc |
| Jul 1, 2016 | The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB... | The seal between the balloon and the housing may leak. | Class II | Circulatory Technology Inc |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 22, 2016 | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ... | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a... | Class III | Ortho-Clinical Diagnostics |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 1... | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling ... | Class II | Amd-Ritmed, Inc. |
| May 27, 2016 | Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de... | The primary packaging of these products may show leaks in individual cases. As a consequence, the... | Class II | Ivoclar Vivadent, 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.