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

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 3, 2020 Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... Class III Pega Medical Inc.
Oct 2, 2019 SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm ... There is a potential for the screws to have become loosened during ultrasonic cleaning of the kno... Class II Pega Medical Inc.
May 29, 2019 SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedu... Handle could jam with the Driver due to the detachment of an internal Connector Ring. Class II Pega Medical Inc.
Oct 20, 2015 SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of th... SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the f... Class II Pega Medical Inc.
Jun 15, 2015 Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Scr... SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instrum... Class II Pega Medical Inc.
Apr 10, 2015 Female Driver, Part number FDr101, instrument used for the insertion of the F... The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0... Class II Pega Medical Inc.
Feb 20, 2015 GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog... Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of t... Class II Pega Medical Inc.
Mar 5, 2014 Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... The outer package label contained the incorrect length of the device. There is a label on the out... Class II Pega Medical Inc.
Feb 7, 2014 Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid ... The Male Components in this lot are made of material with lower strength than manufacturing speci... Class II Pega 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.