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.

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DateProductReasonClassFirm
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.