Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2019 | CBS micro, countersink, cannulated, round-shaft, Item Number 503004341 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 3x90mm, AO, Item Number ST502015631 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, contra-angle, 1.5x85mm, Item Number ST502015706 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 50... | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 5, 2019 | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P... | In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 5, 2019 | Alinity i Processing Module, 03R65 01, with the below components. a. TED (... | Potential loose cable connections on the reagent cooler, which could result in temperature errors... | Class II | Abbott Gmbh & Co. KG |
| Apr 4, 2019 | cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... | There is a potential for the tray input flap on the post analytical units to become loose, potent... | Class III | Roche Diagnostics Corporation |
| Apr 4, 2019 | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... | There is a potential for the tray input flap on the post analytical units to become loose, potent... | Class III | Roche Diagnostics Corporation |
| Apr 4, 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... | The manufacturer received complaints that customers were attempting to install the fitting softwa... | Class III | Advanced Bionics, LLC |
| Apr 3, 2019 | DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR T... | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFi... | Class II | Delfi Medical Innovations, Inc. |
| Apr 3, 2019 | Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 4... | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) Ig... | Class II | Bio-Rad Labs |
| Apr 3, 2019 | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance... | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or othe... | Class II | Elekta Limited |
| Apr 3, 2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Pro... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| Apr 3, 2019 | BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Ve... | Background calibration has the potential to cause false positive or false negative test results. ... | Class II | Becton Dickinson & Co. |
| Apr 3, 2019 | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff... | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFi... | Class II | Delfi Medical Innovations, Inc. |
| Apr 3, 2019 | BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System ... | Background calibration has the potential to cause false positive or false negative test results. ... | Class II | Becton Dickinson & Co. |
| Apr 3, 2019 | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article ... | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become ... | Class II | Thommen Medical AG |
| Apr 3, 2019 | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Produc... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| Apr 3, 2019 | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... | Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bat... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model N... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)0019070701651... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 2, 2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model ... | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... | Class II | Thermo Fisher Scientific (Asheville) LLC |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 1, 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm... | The firm received reports indicating that the laser guard foil partially separated and/or slightl... | Class II | Teleflex Medical |
| Apr 1, 2019 | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... | Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... | Class II | Zimmer Biomet, Inc. |
| Apr 1, 2019 | Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Us... | There is a potential for the single use suction valve to come apart and/or remain stuck inside th... | Class II | Olympus Corporation of the Americas |
| Apr 1, 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm... | The firm received reports indicating that the laser guard foil partially separated and/or slightl... | Class II | Teleflex Medical |
| Apr 1, 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm... | The firm received reports indicating that the laser guard foil partially separated and/or slightl... | Class II | Teleflex Medical |
| Apr 1, 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm... | The firm received reports indicating that the laser guard foil partially separated and/or slightl... | Class II | Teleflex Medical |
| Apr 1, 2019 | da Vinci SP surgical system | Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the ... | Class II | Intuitive Surgical, Inc. |
| Apr 1, 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. m... | The firm received reports indicating that the laser guard foil partially separated and/or slightl... | Class II | Teleflex Medical |
| Apr 1, 2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... | Pin hole package failures compromising sterility of product | Class II | Dornier Medtech America, Inc. |
| Mar 31, 2019 | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra ... | Stability did not meet acceptance criteria for visual appearance during mixing and force vs. disp... | Class II | Integra Limited |
| Mar 31, 2019 | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 | A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of lo... | Class II | Verathon, Inc. |
| Mar 30, 2019 | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 30, 2019 | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 29, 2019 | Precision 500D The Precision 500D R&F X-ray System is intended to be used... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 29, 2019 | Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT S... | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... | Class II | Conformis, Inc. |
| Mar 29, 2019 | Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT S... | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/he... | Class II | Conformis, Inc. |
| Mar 29, 2019 | Sterile Nail Nipper, Barrel Spring (I68400), Sterile | Compromised seal on the sterile barrier pouch. | Class II | Centurion Medical Products Corporation |
| Mar 29, 2019 | Proteus XR/a The Proteus XR/a radiographic system offers the flexibility ... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 29, 2019 | Silhouette VR This fully integrated system offers intuitive controls with... | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... | Class II | GE Healthcare, LLC |
| Mar 29, 2019 | Sterile Nail Clipper Concave Edge (67710) | Compromised seal on the sterile barrier pouch. | Class II | Centurion Medical Products Corporation |
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.