Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2017 | ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 D... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2017 | AUTO REF/KERATOMETER ARK-1s | There is possibly a difference between the measured dioptric value of the subjective measurement ... | Class II | Nidek Inc. |
| Dec 20, 2017 | ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAI... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2017 | ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL ... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2017 | ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nai... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2017 | Disposable Drill Kit which includes two drill bits, two drill stops, and two ... | There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 conta... | Class II | Ad-Tech Medical Instrument Corporation |
| Dec 20, 2017 | ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 D... | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... | Class II | Zimmer Biomet, Inc. |
| Dec 19, 2017 | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, art... | Missing drill guide as stated in the package. | Class II | Paragon 28, Inc. |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 0527196... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMM... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Prod... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each devi... | There is a possibility of the heparin line is occluded. | Class II | Nipro Medical Corporation |
| Dec 19, 2017 | CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Nu... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray wit... | DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tr... | Class II | DeRoyal Industries Inc |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI ... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 063965180... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-5... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 059... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche G... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche ... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitr... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S... | The product is labeled with the incorrect expiration date. | Class III | LivaNova USA |
| Dec 19, 2017 | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Numb... | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... | Class II | Cook Inc. |
| Dec 19, 2017 | ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GM... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p... | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 18, 2017 | Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometr... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 18, 2017 | cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoC... | The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. | Class II | Phadia US Inc |
| Dec 18, 2017 | c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 mod... | Complaints have been received concerning questionable results on analyzers due to customers utili... | Class II | Roche Diagnostics Corporation |
| Dec 18, 2017 | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (10... | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2017 | COACH¿ Self-Adhering Sports Wrap (size: 3in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbe... | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukoc... | Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduc... | Class II | Terumo Cardiovascular Systems Corp |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Cur... | Package integrity failure observed during routine shift package integrity testing at an external ... | Class II | Johnson & Johnson Vision Care, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP ... | The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | Class II | Phadia US 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.