Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 16, 2018 | MED EL Cochlear Implant System, SONATATIi100, sold under the following implan... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 10, 2018 | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... | Class II | Baxter Healthcare Corporation |
| Oct 9, 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... | This recall has been initiated due to a software defect found in the Guide System software when u... | Class I | Synaptive Medical Inc |
| Oct 5, 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066... | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ... | Class I | GE Healthcare, LLC |
| Sep 21, 2018 | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos... | The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ... | Class III | Becton Dickinson & Co. |
| Sep 14, 2018 | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac... | Potential to lead to a false negative results. | Class II | Luminex Corporation |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... | Class II | Bayer Medical Care, Inc. |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ... | There is a potential for increased imprecision, out of range quality controls and prolonged sampl... | Class II | Instrumentation Laboratory Co. |
| Jul 30, 2018 | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P... | The item is labeled as an 8.3mm, but it is actually a 12 mm. | Class II | Zimmer Biomet, Inc. |
| Jul 3, 2018 | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient ... | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the ... | Class II | ConvaTec, Inc |
| Jul 2, 2018 | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll... | From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried o... | Class II | Radiometer America Inc |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... | Mislabeled hook pouch included a transport/storage label rather than the product label containin... | Class II | Nico Corp. |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 8, 2018 | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... | Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... | Class II | Luminex Corporation |
| Apr 30, 2018 | PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... | Class II | Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr... |
| Apr 30, 2018 | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... | Class II | Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr... |
| Apr 25, 2018 | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... | A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... | Class II | Conseal International, Inc. |
| Apr 20, 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... | Complaints where users were unable to prime the administration set. | Class II | CareFusion 303, Inc. |
| Apr 19, 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be ... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 2, 2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The P... | The connector of the power supply was capable of fitting other components provided with the syste... | Class II | Bio-Rad Laboratories Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Tornier, Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 23, 2018 | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 16, 2018 | Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 15, 2018 | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... | Class II | Biocare Medical, LLC |
| Mar 12, 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... | This device was mislabeled and is not the correct component for this patient. | Class II | TMJ Solutions Inc |
| Mar 12, 2018 | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c... | Products have been packaged with the wrong Trocar length type. | Class II | CooperSurgical, Inc. |
| Jan 2, 2018 | Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... | The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... | Class II | Roche Diagnostics Corporation |
| Dec 20, 2017 | ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ... | 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 ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST... | 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 NAIL 125 DEG X 9MM STER TROC NAIL 13... | 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 END CAP STER TROC END CAP 5MM STER ... | 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 ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ... | 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 TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ... | 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 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 | 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 | 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 15, 2017 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... | Class II | DePuy Spine, 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.