Browse Device Recalls
3,282 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,282 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 3,282 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2019 | K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Expre... | There is a potential for weak seals of the sterile packaging. | Class II | Zimmer Biomet, Inc. |
| May 28, 2019 | DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: The... | There is a potential for weak seals of the sterile packaging. | Class II | Zimmer Biomet, Inc. |
| May 28, 2019 | DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: Th... | There is a potential for weak seals of the sterile packaging. | Class II | Zimmer Biomet, Inc. |
| May 23, 2019 | Various products which were contract sterilized. | The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. | Class II | Anewmed Corporation |
| May 2, 2019 | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT | The products may have been manufactured without the bottom seal on the outer packaging, compromis... | Class II | Cook Inc. |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| 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 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. |
| Mar 19, 2019 | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... | During manufacture, packaging materials for a small portion of the lot may not have been properly... | Class II | Stryker Instruments Div. of Stryker Corporation |
| 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 11, 2019 | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive ... | One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited num... | Class II | Johnson & Johnson Vision Care, Inc. |
| Feb 27, 2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numb... | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA... | Class III | Cypress Medical Products LLC |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 15, 2019 | Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosu... | Potential for the sterile packaging to be compromised | Class II | Covidien, PLC |
| Feb 13, 2019 | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device inten... | The firm became aware of the potential for the products' sterile pouch to be punctured during tra... | Class II | Bioventus, LLC |
| Feb 8, 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... | The integrity of the sterile grid packaging is potentially compromised. | Class II | Riverpoint Medical, LLC |
| Feb 7, 2019 | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui... | Frayed pieces of the mounting card being inside the primary packaging. | Class III | Cordis Corporation |
| Jan 16, 2019 | daVinci Harmonic ACE Curved Shears | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... | Class II | Intuitive Surgical, Inc. |
| Jan 9, 2019 | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 9, 2019 | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: ... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 9, 2019 | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 9, 2019 | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific 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.