Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2015 | NobelReplace CC RP 4.3x13mm, Article No. 36708. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 5.0x13mm, Article No. 36713. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| 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 | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; L... | Internal gas line may malfunction causing the line to burst under pressure. | Class II | CooperSurgical, Inc. |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| 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 | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Den... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF... | GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ... | Class II | GE Healthcare |
| 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 | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalan... | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated... | Class II | In2Bones, SAS |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x11.5mm, Article No. 36707. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 5.0x10mm, Article No. 36711. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is use... | Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Fa... | Class II | Bacterin International, Inc. |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's De... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x10mm, Article No. 36705. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| 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 | Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, ... | GE Healthcare has recently become aware of an improper installation of a ceiling suspended penden... | Class II | GE Healthcare |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC NP 3.5x11.5mm, Article No. 36701. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| 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 | NobelReplace CC NP 3.5x13mm, Article No. 36702. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x8mm, Article No. 36704. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's ... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indic... | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that g... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2015 | NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC NP 3.5x10mm, Article No. 36700. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| 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 | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 ... | Fujifilm is conducting a corrective action due to an FDA inspection. | Class II | Fujifilm Medical Systems U.S.A., 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. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, 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.