Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Aug 3, 2017 Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage:... The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on... Class II OrthoPediatrics Corp
Aug 3, 2017 Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 2, 2017 Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications... Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak du... Class II Haemonetics Corporation
Aug 2, 2017 JANUS & JANUS G3 Automated Workstation is an automated programmable liquid h... We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were... Class III Perkinelmer Life Sciences, Inc.
Aug 2, 2017 The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha... Class I OriGen Biomedical, Inc.
Aug 2, 2017 Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Instrumentation Laboratory Co. received customer reports of performance issues with some vials of... Class II Instrumentation Laboratory Co.
Aug 2, 2017 Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications f... Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak du... Class II Haemonetics Corporation
Aug 2, 2017 Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, n... The plastic core of the Decorticating Planer was found to be missing, which could result in scori... Class II Orthofix, Inc
Aug 1, 2017 Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Aug 1, 2017 Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Aug 1, 2017 Presource(R) Kits (custom surgical/procedural kits): The standard and custom... The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... Class II Cardinal Health 200, LLC
Aug 1, 2017 GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF... Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing G... Class II Smith & Nephew, Inc.
Jul 31, 2017 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Ro... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blo... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregn... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, R... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, S... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand P... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotatin... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Rem... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gan... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 3... The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR30... Class II Oakworks Inc
Jul 31, 2017 Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog... Central venous catheters may not fit over guide wire potentially causing procedure delay. Class II Cook Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Cle... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, 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.