EasyPoint® 82011Recalls & reported problems
Retractable Technologies, Inc. · 25G x 1" EasyPoint® Needle · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613703820105), received between Mar 6, 2020 and Aug 13, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (1 report).
1 other recall cover devices cleared under the same FDA submission (K133635); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fail-Safe Did Not Operate1
- Retraction Problem1
Patient problems
- Exposure to Body Fluids1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2020Fail-Safe Did Not Operate
TUESDAY JULY 14TH AT APPROXIMATELY 3:00PM AN RN FROM THE (B)(6) CLINIC FROM (B)(6) HEALTH MEDICAL SERVICES WAS ADMINISTERING A VACCINE TO A PATIENT. AFTER PERFORMING THE INTRAMUSCULAR INJECTION THE RN ATTEMPTED TO ENGAGE THE INNATE SAFETY MECHANISM TO SHEATH THE NEEDLE. AFTER APPLYING PRESSURE THE RN'S HAND SLIPPED AND LACERATED THEIR LEFT UPPER THIGH. THE RN IMMEDIATELY WASHED THE AFFECTED AREA AND PLACED A BAND-AID ON THE WOUND. THE RN IMMEDIATELY NOTIFIED THE INFECTION CONTROL NURSE AND THE DIRECTOR OF NURSING. THE NURSE VISITED (B)(6) HEALTH FOR MEDICAL TREATMENT. THEIR PPE CONSISTED OF A SURGICAL MASK, GLOVES AND FACE SHIELD. EH&S IS INVESTIGATING THE 25G X1" EASYPOINT NEEDLE'S FAILURE TO NOTIFY THE MANUFACTURER OF THE MALFUNCTIONING DEVICE. THE LOT NUMBER IS K128A. EXPIRATION: 4/28/2024, MANUFACTURER EASYPOINT. REPORTING ON BEHALF OF INJURED NURSE FROM (B)(6) UNIVERSITY (B)(6) MEDICAL CENTER OCCUPATIONAL SERVICES WHO INJURED THEMSELVES ATTEMPTING TO ENGAGE ENGINEERED SHARP AFTER PERFORMING INVESTIGATION. PHI REGARDING TESTING WAS NOT PROVIDED ALTHOUGH PERSONNEL POTENTIALLY EXPOSED TO BBP ARE OFFERED POST EXPOSURE PROPHYLAXIS AND UNDERGO BASELINE SEROLOGY AS PART OF (B)(6) MED
Patient problems: Exposure to Body Fluids
MAUDE report 10407229 ↗MalfunctionMar 6, 2020Retraction Problem
NURSE PRACTITIONER ADMINISTERED VACCINE AND NOTICED THAT THE NEEDLE DID NOT RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9797797 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133635. One submission often covers many models, so check the product and lot details in each record.
- Z-1293-2024 · Feb 5, 2024 · Open, ClassifiedEasyPoint Needle, 25G x 5/8", REF: 82091
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.