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 | Drill, cannulated, 4x90mm, round shaft, Item Number 502015640 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 107587... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Aur... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Mo... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) ... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number ... | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill Sys2.7, 2x103mm, AO, Item Number 502015107 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL ... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", micro-countersink, round shaft, Item Number 28.66.112 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The A... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | CBS micro, countersink, cannulated, AO, Item Number 503004541 | 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 502015631 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, ... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | Drill, contra-angle, 1.5x85mm, Item Number 502015706 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2x95mm, AO, Item Number 502015623 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) ... | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... | Class II | Ortho-Clinical Diagnostics |
| Apr 8, 2019 | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, M... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
| Apr 8, 2019 | LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS902... | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... | Class I | Integra LifeSciences Corp. |
| Apr 8, 2019 | Drill, 3.2x145mm, AO, Item Number ST502015650 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System ... | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... | Class I | Integra LifeSciences Corp. |
| Apr 8, 2019 | CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 2.5x135mm, AO, Item Number 502015142 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.8x120mm, AO, Item Number 502015628 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS high, countersink, cannulated, round-shaft, Item Number 503004342 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2x95mm, round shaft, Item Number 502015619 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", Micro-countersink, AO, Item Number 28.66.113 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS 7.5 tap, cannulated, AO, Item Number 503002041 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | Drill, cannulated, 4x120mm, AO, Item Number ST502015402 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 3x90mm, round shaft, Item Number 502015630 | 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, AO, Item Number 502015638 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.8x150mm, AO, Item Number 502015629 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.5x95mm, AO, Item Number 502015621 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The A... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... | Class II | Boston Scientific Corporation |
| Apr 8, 2019 | Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #... | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Compass Health Brands (Corporate Office) |
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.