Browse Device Recalls
66 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 66 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 66 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 17, 2021 | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Due to 16 complaints related to drivers not engaging in implants. According to the firm's invest... | Class II | Nobel Biocare Usa Llc |
| Aug 28, 2019 | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components direct... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components ... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic co... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with ... | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tight... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components dire... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directl... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Jul 19, 2019 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... | The top label for dental implant may incorrectly indicate the implant length. Specifically, the l... | Class II | Nobel Biocare Usa Llc |
| May 28, 2019 | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747... | Packaged dental implant healing abutments were found to contain the wrong size device. | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instrument... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Kit - Product Usage: The kit itself does not have a specifi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They ca... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: Th... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twis... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Tw... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments f... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (St... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended t... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 16, 2018 | Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... | The product label has missing information, such as the lot number and expiration date, as well as... | Class II | Nobel Biocare Usa Llc |
| Jul 20, 2016 | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instruc... | Incorrect drill protocol in the Instructions for Use (IFU) | Class II | Nobel Biocare Usa Llc |
| Jun 22, 2016 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... | Incorrect top label on an implant package. | Class II | Nobel Biocare Usa Llc |
| Jun 22, 2015 | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutme... | One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used t... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. 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 RP 4.3x10mm, Article No. 37291. | 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 5.0x8mm, Article No. 36710. | 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 NP 3.5x10mm, Article No. 29401. 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 4.3x13mm, 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 | 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 | 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 | 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 | 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 |
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.