Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2015 | Arthroscopy Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Mississippi Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Lima Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 14, 2015 | KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Produc... | The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adult... | Class II | Halyard Health, Inc |
| Mar 9, 2015 | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Compon... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance ... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/p... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 2... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is us... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A H... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21,... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Mar 9, 2015 | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC ... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, Inc. |
| Feb 19, 2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... | Class III | Arc Medical Inc |
| Jan 30, 2015 | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... | Potential breach of the sterile barrier packaging. | Class II | C.R. Bard, Inc. |
| Jan 29, 2015 | Elekta Precise Treatment Table | It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are d... | Class II | Elekta, Inc. |
| Jan 16, 2015 | KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 16, 2015 | KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 16, 2015 | KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Steril... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 7, 2015 | Precise Digital Accelerator Intended to be used for radiation therapy trea... | Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack ma... | Class II | Elekta, Inc. |
| Dec 19, 2014 | Monaco radiation therapy treatment planning system. The Monaco system i... | Incorrect CT to ED when using the Monaco Image Statistics Tool. | Class II | Elekta, Inc. |
| Dec 19, 2014 | Focal Sim radiation therapy treatment planning system | Incorrect CT to ED when using the Monaco Image Statistics Tool. | Class II | Elekta, Inc. |
| Dec 11, 2014 | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN... | The dials in the Autopens are not working - the dial does not stay dialed, but springs right back... | Class II | Owen Mumford USA, Inc. |
| Nov 24, 2014 | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 ... | The syringe carrier is missing components: a damper and spring. | Class II | Owen Mumford USA, Inc. |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 3, 2014 | MOSAIQ Product Usage: MOSAIQ is an oncology information system used to ma... | A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose ro... | Class II | Elekta, Inc. |
| Oct 7, 2014 | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske... | The product is non-sterile. | Class II | C.R. Bard, Inc. |
| Oct 6, 2014 | Laksell Gamma Knife Perfexion | Elekta has become aware that the latches may be locked before they have been fully turned resulti... | Class II | Elekta, Inc. |
| Aug 27, 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon... | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo... | Class II | Mckesson Information Solutions LLC |
| Aug 18, 2014 | Monaco The Monaco system is used to make treatment plans for patients wit... | Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic ... | Class II | Elekta, Inc. |
| Aug 18, 2014 | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for pat... | When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Com... | Class II | Elekta, Inc. |
| Jun 25, 2014 | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for comple... | McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to es... | Class II | Mckesson Information Solutions LLC |
| May 29, 2014 | MOSAIQ MOSAIQ is an oncology information system used to manage workflows f... | MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other t... | Class II | Elekta, Inc. |
| May 29, 2014 | iGUIDE System Product Usage: The intended use of the device is the contro... | A bug in the software prevents the iGUIDE software from logging off. | Class II | Elekta, Inc. |
| May 23, 2014 | MOSAIQ, an oncology information system used to manage workflows for treatment... | When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and th... | Class II | Elekta, Inc. |
| Apr 25, 2014 | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (Bio... | Serum albumin component monomer failed to meet internally established end of shelf-life specifica... | Class II | CryoLife, Inc. |
| Apr 23, 2014 | Synergy XVI Intended for radiation therapy treatment. | XVI can incorrectly calculate the target position of the treatment table. | Class II | Elekta, Inc. |
| Apr 17, 2014 | HexaPOD evo RT Couchtop. To support and aid in positioning a patient durin... | If screws are not properly tightened with a torque wrench they may become loose over time. | Class II | Elekta, Inc. |
| Mar 5, 2014 | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. El... | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically... | Class II | Remington Medical Inc. |
| Feb 17, 2014 | XiO RPT System The XiO RTP System is used to create treatment plans for an... | Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used wit... | Class II | Elekta, Inc. |
| Feb 12, 2014 | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indi... | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 ... | Class II | CryoLife, Inc. |
| Feb 3, 2014 | Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega... | Firm is not registered as a drug manufacturer. | Class II | Altasource LLC dba Meta Labs LLC |
| Feb 3, 2014 | Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA ... | Firm is not registered as a drug manufacturer. | Class II | Altasource LLC dba Meta Labs LLC |
| Feb 3, 2014 | Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8... | Firm is not registered as a drug manufacturer. | Class II | Altasource LLC dba Meta Labs LLC |
| Feb 3, 2014 | Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical g... | Firm is not registered as a drug manufacturer. | Class II | Altasource LLC dba Meta Labs LLC |
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.