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 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
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

228 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 228 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 228 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 28, 2022 Regard IV Start Kit for preparing and/or dressing a peripheral vein intraveno... A kit component, the PDI Prevantics Swab, was recalled. Class II Resource Optimization & Innovation LLC
Jun 17, 2020 regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 33557... The firm received reports from customer that the Regard Migrating Indicator shown malfunctions an... Class II Resource Optimization & Innovation LLC
May 4, 2020 Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline... There is a potential for the product to exhibit holes in the packaging, which impacts package int... Class II Resource Optimization & Innovation LLC
May 4, 2020 Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Fl... There is a potential for the product to exhibit holes in the packaging, which impacts package int... Class II Resource Optimization & Innovation LLC
Sep 25, 2017 Regard Custom Surgical Pack Packs contain surgical instruments and accesso... Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect l... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Children... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St F... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Sa... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical C... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Chil... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens S... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Sa... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Sa... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Cent... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation 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.