EasyPointRecalls & reported problems across all models
Retractable Technologies, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EasyPoint model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 3 models of EasyPoint by Retractable Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2018 and May 1, 2024 — classified as 2 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (7 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EasyPoint recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 5, 2024Open, Classified
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Z-1293-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported EasyPoint problems
Device problems
- Retraction Problem7
- Break2
- Fail-Safe Did Not Operate2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Material Separation1
- Mechanical Jam1
- Output Problem1
Patient problems
- No Known Impact Or Consequence To Patient9
- Insufficient Information3
- Device Embedded In Tissue or Plaque1
- Discomfort1
- Exposure to Body Fluids1
- Foreign Body In Patient1
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
EasyPoint models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EasyPoint® 82091Needle, Hypodermic, Single Lumen1 recall15 reports
- EasyPoint® 82011Needle, Hypodermic, Single Lumen2 reports
- EasyPoint® 85291Needle, Hypodermic, Single Lumen1 report
Recent EasyPoint adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024
REGISTERED NURSE (RN) ADMINISTERED SC HEPARIN AS ORDERED. WHEN SHE RETRACTED NEEDLE AFTER ADMINISTRATION, NEEDLE REMAINED IN PATIENT'S ABDOMEN.
Patient problems: Foreign Body In Patient
MAUDE report 19220467 ↗MalfunctionMar 18, 2024
WHILE DRAWING UP HEPARIN THE NEEDLE CAME OUT OF THE RETRACTABLE HUB. THE NEEDLE WAS STUCK IN THE VIAL.
Patient problems: Insufficient Information
MAUDE report 18920631 ↗MalfunctionMar 18, 2024
RN PULLED AN EASYPOINT 25G NEEDLE OUT OF THE SUPPLY CART AND NOTICED THE ORIGINAL NEEDLE INTACT INSIDE THE SAFETY CAP, AS WELL AS AN EXTRA LOOSE NEEDLE INSIDE OF THE PACKAGING.
Patient problems: Insufficient Information
MAUDE report 18920629 ↗MalfunctionJan 24, 2024
RN WENT TO ENGAGE SAFETY MECHANISM OF INTRAMUSCULAR NEEDLE AND THE ENTIRE INTRAMUSCULAR NEEDLE TOP FELL APART INTO MANY PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18571315 ↗InjuryJan 18, 2024Material Separation; Material Separation
INITIAL REPORT OF NEEDLE SEPARATION IN PATIENT WAS SUBMITTED BY VACCINE MANAGER OF USER FACILITY ON NOVEMBER 9, 2023. THE INITIAL INFORMATION WAS REPORTED AS FOLLOWS: NURSE GAVE FLUE VACCINE IN CHILD'S THIGH. WHEN SHE WENT TO RETRACT THE NEEDLE IT WENT INSIDE OF THE PATIENT'S THIGH. THE PATIENT WENT TO HOSPITAL AND HAD TO HAVE IT REMOVED VACCINE MANAGER REPORTED THAT FACILITY DID NOT RETAIN INVOLVED PRODUCT BUT HAD ASSOCIATED PRODUCT. SHIPPING CONTAINERS WERE SENT FOR RETURN OF ASSOCIATED PRODUCT AND RECEIPT WAS CONFIRMED ON NOVEMBER 17, 2023. NOVEMBER 17, 2023 REPORTING VACCINE MANAGER TO FOLLOW UP REGARDING TREATMENT AND OUTCOME OF PATIENT INVOLVED IN THE INCIDENT. ASSOCIATED PRODUCT WAS RECEIVED AND TESTING WAS COMPLETED ON DECEMBER 28, 2023. ALL SAMPLES RETURNED WERE TESTED AND WERE WITHIN SPECIFICATION. VACCINE MANAGER PROVIDED FOLLOW UP INFORMATION ON NOVEMBER 29, 2023 STATING THAT THE PATIENT'S MOTHER RETURNED TO THE HOSPITAL AND THE NEEDLE WAS SURGICALLY REMOVED BY THE HOSPITAL. THE SAME DAY VACCINE MANAGER PROVIDED AN IMAGE OF A DETACHED NEEDLE, AN XRAY OF NEEDLE IN PATIENT'S THIGH AND AN XRAY THAT SHOWS NO NEEDLE. ON DECEMBER 19, 2023 THE VACCINE MANAGER REPORTED THAT NO
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18539548 ↗MalfunctionJun 15, 2023Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED TO THE INFUSION CENTER FOR VIDAZA INJECTIONS. PATIENT REPORTS SIGNIFICANT PAIN/DISCOMFORT WITH OUR CURRENT NEEDLE SYSTEM. EASYPOINT NEEDLE: 25G X 5/8". RETRACTABLE TECHNOLOGIES INC LOT: K211201. PATIENT REQUESTS THAT NURSING REMOVE THE NEEDLE AND THEN DISENGAGE TO DECREASE THE PAIN.
Patient problems: Discomfort; Pain
MAUDE report 17134036 ↗MalfunctionApr 7, 2023Break
WHILE ADMINISTERING SUBCUTANEOUS HEPARIN, REGISTERED NURSE ATTEMPTED TO RETRACT THE NEEDLE. THE SAFETY NEEDLE BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 16701379 ↗MalfunctionJul 22, 2022Retraction Problem
RETRACTING NEEDLE DID NOT OPERATE CORRECTLY CAUSING RN TO STICK HERSELF.
Patient problems: Needle Stick/Puncture
MAUDE report 15084187 ↗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 ↗MalfunctionNov 13, 2019Break; Unintended Ejection
AFTER ADMINISTERING FLU VACCINE, NEEDLE SAFETY DEVICE ACTIVATED BY PRESSING ORANGE BUTTON, NEEDLE SHOT INTO AIR AND BOTH HUB AND NEEDLE MECHANISM BROKE INTO PIECES. PIECES WERE ABLE TO BE RECOVERED AND NO ONE WAS HURT OR HIT BY ANY OF THE PIECES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9314669 ↗MalfunctionJun 18, 2019Output Problem; Fail-Safe Did Not Operate
PATIENT WAS GIVEN THE SQ HEPARIN INJECTION AND SAFETY NEEDLE WOULD NOT FUNCTION. NURSE TRIED TO ACTIVE THE SAFETY MECHANISM 3 TIMES WITHOUT SUCCESS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8707109 ↗MalfunctionJun 4, 2019Retraction Problem
RN WAS GIVING THE PATIENT HIS EVENING HEPARIN INJECTION SQ IN THE LOWER LEFT QUADRANT OF THE ABDOMEN. ONCE THE HEPARIN WAS INSTILLED, RN WENT TO RETRACT THE NEEDLE UTILIZING THE BUTTON ON THE EASYPOINT 25G X 5/8" NEEDLE AND THE BUTTON DID NOT RETRACT. THE NEEDLE WAS RETRACTED MANUALLY FROM THE PATIENT'S INJECTION SITE. AFTER A SECOND ATTEMPT TO CLICK THE BUTTON ON THE EASYPOINT NEEDLE, THE SPRING FINALLY RELEASED AND THE NEEDLE RETRACTED BACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8666563 ↗MalfunctionMar 12, 2019Retraction Problem
RN WAS ADMINISTERING SC HEPARIN INJECTION TO PATIENT AND SAFETY NEEDLE DID NOT RETRACT. RN NOTICED ON REMOVING THE HEPARIN SYRINGE THAT NEEDLE WAS NOT RETRACTED. NEITHER RN NOR PATIENT WERE STUCK BY NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8412081 ↗MalfunctionMar 4, 2019Retraction Problem
RETRACTABLE NEEDLE DID NOT RETRACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8385885 ↗
Other Retractable Technologies, Inc. products
All Retractable Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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