Walgreens 677257Recalls & reported problems
Walgreen CO. · Walgreens Insulin Syringes 0.3mL 29Gauge 1/2" (12.7mm) U-100 100count · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00311917014920), received between Feb 13, 2018 and Sep 26, 2026 — classified as 1 injury, 21 malfunctions.
The most frequently reported specific device problem is “Volume Accuracy Problem” (8 reports).
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.
Reports received per month
Most reported problems
Device problems
- Volume Accuracy Problem8
- Leak/Splash3
- Device Markings/Labelling Problem2
- Defective Device1
- Detachment of Device or Device Component1
- Difficult to Advance1
- Failure to Deliver1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient8
- Exposure to Body Fluids1
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907925 ↗MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907905 ↗MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907891 ↗MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907876 ↗MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907828 ↗MalfunctionSep 26, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907798 ↗MalfunctionSep 26, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907748 ↗MalfunctionSep 2, 2025Volume Accuracy Problem; Volume Accuracy Problem
CONSUMER REPORTED THAT THE SCALE PRINT ON 8 SYRINGES FROM ONE PACKAGE WERE MIS-ALIGNED. LOT #: 4282084. CATALOG #: 928852. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT. VCOYNE 18AUGUST2025. UPDATE/ADDITIONAL INFORMATION FROM NACC. THIS IS A FOLLOW UP TO SF00025457. I REALIZED THAT I DID NOT INCLUDE IN THE VERBATIM THAT THE CONSUMER USED ONE OF THE SYRINGES WITH SOME TYPE OF DIGITAL MEASURING DEVICE. HOWEVER, I ADVISED HER NOT TO USE ANY OF THE OTHER SYRINGES THAT ARE MISALIGNED. I HAVE SENT HER A NEW BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22945714 ↗MalfunctionAug 11, 2023Missing Information; Missing Information
IT WAS REPORTED BY THE CUSTOMER THAT A BOX OF BD ULTRA-FINE¿ INSULIN SYRINGE'S DID NOT HAVE THE EXPIRATION DATE PRINTED ON THE BOX. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: FAMILY MEMBER FOUND A BOX OF OLD SYRINGES IN DADS HOME AND NOT USED. EXP DATE IS NOT NOTED ON BOX. NOTED TO CALLER THEY ARE EXPIRED AND TO PROPERLY DISPOSE OF SYRINGES WITHIN HER TOWNS GUIDELINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17514564 ↗MalfunctionNov 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT 1 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE AND THE NEEDLE HUB SEPARATED AND CAME OFF INSIDE OF THE SHIELD. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12774753 ↗MalfunctionMay 13, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 BD INSULIN SYRINGES 0.3ML 29GA 1/2IN SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 928852; BATCH NO. 0125318. IT WAS REPORTED THAT SYRINGE NEEDLES ARE BENT WHEN SHIELD IS REMOVED. ALSO REPORTED NEEDLE HUB SEPARATED INTO THE SHIELD. FROM THE VERBATIM : CONSUMER FOUND 1 SYRINGE WHEN SHIELD REMOVED THE NEEDLE HUB ASSEMBLY WENT OFF SYRINGE WITH THE SHIELD. CONSUMER FOUND THE NEEDLES WERE BENT WHEN REMOVED NEEDLE SHIELD. DATE OF EVENT : (B)(6) 2021 SAMPLES STATUS : DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11817115 ↗MalfunctionApr 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A BOX OF SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE EXPIRATION DATES WERE NOT ON THE BOX. VERBATIM: PHARMACY REPORTED FOUND FULL BOX OF WALGREENS INSULIN SYRINGE 30G, 0.3ML 8MM WITH LOT # 6347590. LOT # 6347590. CATALOG# 928855. DATE OF EVENT (B)(6) 2021. SAMPLE NO. PHARMACY REPORTED FOUND FULL BOX OF WALGREENS INSULIN SYRINGE WITHOUT EXP DATES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11692925 ↗MalfunctionSep 1, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG EXPERIENCED OPEN UNIT PACKAGING/SEALS WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITHOUT A PLUNGER CAP. CONSUMER REPORTED ANOTHER BAG FROM THIS BOX -WITH A EXTRA NEEDLE SHIELD LAYING IN THE BAG. LOT #: 9042915B. CATALOG#: 928852. DATE OF EVENT: (B)(6) 2020. CONSUMER IS DISABLED AND HAS A FRIEND PICK UP SUPPLIES FROM PHARMACY. CONSUMER DECLINED LEAVING NAME AND DEMOGRAPHICS. DECLINED REPLACEMENT PRODUCT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10475419 ↗InjuryJun 16, 2020Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG EXPERIENCED NEEDLE THROUGH SHIELD AFTER RECAPPING AND RESULTED IN THE DEVICE USER RECEIVING AN UNSPECIFIED NUMBER OF NEEDLE STICK INJURIES. PRODUCT DEFECTS OCCURRED DURING USE. NO MEDICAL TESTING/INTERVENTION WAS SOUGHT/RECEIVED AS A RESULT OF THE DIRTY NEEDLE STICK(S). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:928852 BATCH NO: 9203872. PET OWNER STATED, SHE STUCK HER FINGER AS A RESULT OF RE-SHIELDING AFTER HER PETS INJECTION. NEEDLE PUNCTURE THE SHIELD WHEN SHE RE-SHIELDED. DID NOT SEEK MEDICAL. SUGGESTED WE MAKE SHIELDS THAT ARE PUNCTURE PROOF. EXPLAINED TO PET OWNER NEVER TO RE-SHIELD DATE OF EVENT: (B)(6) 2020.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 10160530 ↗MalfunctionMay 14, 2020Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT PLUNGER ISSUES OCCURRED DURING USE WITH A BD¿ INSULIN SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED PLUNGER ROD DIFFICULT TO MOVE, CONSUMER DOES NOT RE-USE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10059890 ↗MalfunctionDec 31, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD¿ INSULIN SYRINGE WITH NEEDLE HUB SEPARATED INTO THE SHIELD. THIS OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928852, BATCH NO. 8064780. IT WAS REPORTED THAT NEEDLE SHIELD IS HARD TO REMOVED AND 1 NEEDLE HUB SEPARATED INTO THE SHIELD. ISSUE: CONSUMER REPORTED NEEDLE SHIELD IS HARD TO REMOVE. 1 NEEDLE CAME OFF REMAINED IN THE NEEDLE SHIELD. HE USES THE 3/10CC, 29G, 12.7 NEEDLE. CONSUMER USES NEW NEEDLE FOR HIS INJECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9534201 ↗MalfunctionNov 12, 2019Volume Accuracy Problem; Volume Accuracy Problem
IT HAS BEEN REPORTED THAT ONE SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG HAS BEEN FOUND MISSING SCALE MARKINGS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SCALE MARKING WAS MISSING FROM THE SYRINGE. VERBATIM: ISSUE(S): FOUND SCALE MARKING MISSING ON THE SYRINGE. LOT #: 8344562A. DATE OF EVENT: UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9309172 ↗MalfunctionAug 29, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT NEEDLE HUB SEPARATION OCCURRED WITH A SYRINGE 0.3 ML 29 GA 1/2 IN 10BAG 500 PL/WG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PET OWNER STATED, HE WAS TOLD TO CALL IN BY HIS PHARMACIST, (SHE PROVIDED HIM WITH CS0014365). STATED, SHIELDS ARE DIFFICULT TO REMOVE ON SOME OF THE SYRINGES STATED, WHEN HE PULLED REALLY HARD TO GET SHIELD OFF, NEEDLE AND HUB GOT STUCK IN SHIELD. HAPPENED A FEW TIMES."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8944950 ↗MalfunctionAug 22, 2019Defective Device; Defective Device
IT WAS REPORTED THAT BD¿ INSULIN SYRINGES WERE DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928852, BATCH NO: 8253790. IT WAS REPORTED THAT THE CONSUMER WAS FINDING TWO PACKAGES IN BOX WITH 9 SYRINGES ONLY. STATED FINDING SYRINGES WITH STOPPERS THAT ARE STUCK TO BARREL, SO HE HAS TO MOVE PLUNGER BACK AND FORTH TO LOOSEN. ONCE ITS LOOSE, HE'S ABLE TO USE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8921177 ↗MalfunctionOct 17, 2018Loose or Intermittent Connection
IT WAS REPORTED THAT BD¿ INSULIN SYRINGE WITH NEEDLE HAD A LOOSE PLUNGER ROD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7974682 ↗MalfunctionJun 28, 2018Difficult to Advance
IT WAS REPORTED THAT THE PLUNGER ROD OF A BD¿ INSULIN SYRINGE WITH NEEDLE WAS ¿HARD TO MOVE¿. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7648230 ↗MalfunctionFeb 13, 2018Device Markings/Labelling Problem
IT WAS REPORTED THAT THE SCALE MARKINGS ON A BD¿ INSULIN SYRINGE WITH NEEDLE WERE INCORRECT (DESCRIBED AS ¿SOME ARE UP AT THE TOP AND OTHERS ARE A HALF INCH BELOW THE TOP¿). THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7266920 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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