Walgreens 654567Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00311917025360), received between Aug 2, 2018 and Sep 10, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50710340 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50709985 ↗
• MalfunctionSep 6, 2024Break; Break

  CONSUMER REPORTED, NEEDLE BROKE OFF IN VIAL WHILE ATTEMPTING TO DRAW. STATED, SHE WAS ABLE TO REMOVE THE NEEDLE 3 SYRINGES AFFECTED STATED, DOES NOT RE-USED SYRINGES LOT: 2052384 CATALOG: 928857 DATE OF EVENT: 2024-08-08 SAMPLES: NO CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157285 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE - ULTRA-FINE¿ EXPERIENCED A CANNULA THAT BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN THE VIAL AFTER DRAWING THE INSULIN. SHE STATED THAT SHE WAS REMOVING THE NEEDLE FROM THE VIAL WHEN THE NEEDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272478 ↗
• MalfunctionDec 14, 2021Failure to Deliver; Detachment of Device or Device Component; Failure to Deliver; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD SYRINGE 0.5ML 31GA 8MM EXPERIENCED A CASE OF HUB SEPARATION FROM THE DEVICE, AND BEING UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN SHE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED. STATED 2 SYRINGES WOULD NOT DRAW INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006766 ↗
• MalfunctionAug 13, 2021Break; Failure to Deliver; Break; Failure to Deliver

  IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 31GA 8MM CANNULA BROKE OFF.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE BROKE OFF INSIDE OF THE VIAL.DATE OF EVENT : UNKNOWN.SAMPLES : DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321390 ↗
• MalfunctionJul 28, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 1 SYRINGE 0.5ML 31GA 8MM HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED SYRINGES WITH SMEARED SCALE MARKING. DATE OF EVENT : UNKNOWN SAMPLES STATUS : DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239530 ↗
• MalfunctionJun 23, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG WAS UNABLE TO DRAW INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THREE SYRINGES WERE MISSING THE NEEDLE AND TWO SYRINGES WOULD NOT DRAW UP INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051796 ↗
• MalfunctionJun 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 31GA 8MM HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964908 ↗
• MalfunctionMay 25, 2021Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM EXPERIENCED A CASE OF STOPPER DEFORMATION, AND BEING UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 0118327. CONSUMER STATED, STOPPER IS NOT LINED UP CORRECTLY IN BARREL. CONSUMER HAD DIFFICULTY COMMUNICATING WHAT THE ISSUE WAS, STATING SHE SUFFERS FROM DIFFERENT HEALTH PROBLEMS UNRELATED TO ISSUE SHE IS REPORTING. STATED, SHE CANNOT DRAW INSULIN DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882317 ↗
• MalfunctionApr 28, 2021Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG WAS UNABLE TO ASPIRATE AND HAD THE PLUNGER SEPARATES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WILL NOT DRAW UP INSULIN AND THE PLUNGER ROD SEPARATED FROM THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW. ALSO STATED THAT WHEN HE NOTICED THAT THERE WAS NO INSULIN IN THE SYRINGE HE BEGAN TO MOVE THE PLUNGER ROD UP AND DOWN AND THEN THE PLUNGER ROD FLEW OUT OF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742893 ↗
• MalfunctionFeb 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED INSIDE OF SHIELD. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED INSIDE OF THE SHIELD."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11346420 ↗
• MalfunctionFeb 9, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG SEPARATED FROM THE HUB DURING USE, AND A SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE SHIELD WAS HARD TO REMOVE AND ONE SYRINGE THAT THE NEEDLE HUB SEPARATED WHEN THE SHIELD WAS REMOVED. ALSO, ONE SYRINGE WHERE THE NEEDLE BROKE OFF INTO THE CONSUMER'S STOMACH, BUT WAS ABLE TO REMOVE THE NEEDLE WITH TWEEZERS. VERBATIM: CONSUMER REPORTED FOUND 5-6 SYRINGES NEEDLE SHIELD HARD TO REMOVE CONSUMER REPORTED FOUND 1 SYRINGE SHIELD HARD TO REMOVE WHEN REMOVED THE NEEDLE HUB WENT WITH IT. LOT #: 9231296. CATALOG#: 928857. DATE OF EVENT: (B)(6) 2021 NEEDLE HUB REMOVED WITH SHIELD REMOVAL. DATE OF EVENT UNKNOWN FOR THE 5-6 SYRINGES SHIELDS HARD TO REMOVE. SAMPLES STATUS AWAITING SAMPLE. CONSUMER REPORTED 1 SYRINGE WHEN INJECTED INTO STOMACH THE NEEDLE BROKE OFF INTO STOMACH/SITE. SHE WAS ABLE TO REMOVE WITH TWEEZERS ON HER OWN. DENIED REUSE OF NEEDLES.".

  Patient problems: Foreign Body In Patient

  MAUDE report 11305412 ↗
• MalfunctionNov 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 5 SYRINGES 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND IN ONE PACKET 5 SYRINGES WITH A HOLE IN BARREL. INSULIN LEAKED OUT WHEN DRAWING. LOT#: 9189631B, CATALOG#: 928857, DATE OF EVENT: ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10920337 ↗
• MalfunctionNov 20, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG BARREL, AND THE PLUNGER COULDN'T BE PRESSED IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED FOUND FOREIGN MATTER WITHIN THE BARREL LOOKS LIKE HARD CLEAR PLASTIC. CAN'T PRESS THE PLUNGER TO THE TOP, BUT WAS ABLE TO FILL SYRINGE WITH LANTUS AND EXPEL THE LANTUS OUT OF IT. PLASTIC STILL SEEN INSIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10880303 ↗
• MalfunctionNov 2, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG. THIS OCCURRED WITH 4 DIFFERENT SYRINGES. ADDITIONALLY, IT WAS REPORTED THAT THE CONSUMER WAS UNABLE TO DRAW UP MEDICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN REMOVING THE ORANGE CAPS FROM 4 INSULIN SYRINGES, THE NEEDLE COMES OFF WITH THE CAP. STATED HE CALLED ABOUT 3 MONTHS AGO AND REPORTED THE SAME ISSUE. STATED AT THAT TIME HE ALSO HAD ONE SYRINGE THAT HE COULD BARELY REMOVE THE CAP FROM AND ANOTHER SYRINGE THAT WOULD NOT FILL WITH MEDICATION.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10776236 ↗
• MalfunctionOct 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION DATE RECEIVED FOR INTAKE: 29-SEP-2020 CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF SHIELD NEEDLE SHIELD DIFFICULT TO REMOVE. LOT #: 0006836, CATALOG #: 928857, DATE OF EVENT: 09-28-20.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10714745 ↗
• MalfunctionOct 20, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 4 SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG WOULD NOT DRAW UP INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 9231296 & UNKNOWN. IT WAS REPORTED THAT THE CONSUMER FOUND FOUR SYRINGES FROM TWO BOXES THAT WOULD NOT DRAW UP INSULIN. VERBATIM: CONSUMER REPORTED FOUND 4 SYRINGES FROM 2 BOXES THAT WOULD NOT DRAW UP INSULIN. COUPLE CALLING IN THIS CASE. WIFE ASSIST WITH INJECTIONS. FOUND WITHIN THE PAST MONTH TOTAL 4 SYRINGE FROM TWO DIFFERENT BOXES. HAS THE ONE FROM TODAY TO SEND BACK WITH MAILING KIT. HAS NOT CALLED IN THE PAST FOR THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10709070 ↗
• MalfunctionOct 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928857, BATCH NO. UNKNOWN (PROVIDED INVALID LOT #: 9231299). VERBATIM: CONSUMER REPORTED FOUND NEEDLE COMES AWAY FROM SYRINGE WHEN REMOVED SHIELD ON 50-60 SYRINGES. THROUGHOUT LAST 2 BOXES. DATE OF EVENT: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687715 ↗
• MalfunctionAug 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HUB SEPARATED FROM DEVICE WITH A BD SYRINGE 0.5ML 31GA 8MM. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED WITH SHIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457012 ↗
• MalfunctionJul 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 9301568. CONSUMER REPORTED: SHIELDS ARE HARD TO REMOVE AND WHEN HE EVENTUALLY GETS THEM OFF, THE NEEDLE HUB SEPARATES. STATED, ON SOME SYRINGES, WHEN SHIELD IS REMOVED, THE NEEDLE IS BENT AT A 40 DEGREE ANGLE, (NOT ABLE TO USE). NO INJURY TO REPORT. DATE OF EVENT: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10299067 ↗
• MalfunctionMar 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG HUB AND NEEDLE WERE STUCK INSIDE THE SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 9168527. IT WAS REPORTED THAT THE CUSTOMER WAS ONE SYRINGE SHORT AND ALSO THE HUB AND NEEDLE WERE STUCK INSIDE SHIELD. VERBATIM: CONSUMER REPORTED FINDING ONE BAG WITH ONLY 9 SYRINGES INSTEAD OF 10. STATED, THE BAG WAS SEALED. STATED, WHEN SHE REMOVED SHIELD FROM SYRINGE, THE HUB AND NEEDLE ARE NOW STUCK INSIDE SHIELD.

  Patient problems: No Patient Involvement

  MAUDE report 9831890 ↗
• MalfunctionMar 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 9168527. VERBATIM: CONSUMER REPORTED NEEDLE HUB WILL REMOVE WITH SHIELD REMOVAL FOUND 2 SYRINGES WITHIN THIS BOX LOT #: 9168527A CATALOG#: 928857 DATE OF EVENT: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9825930 ↗
• MalfunctionFeb 3, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG HAD A CLEAR LIQUID IN IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 928857 BATCH NO.: 9133772. IT WAS REPORTED THAT A CLEAR LIQUID WAS SEEN WHEN THE PLUNGER IS PUSHED UP. VERBATIM: PHARMACIST CALLED ON BEHALF OF CONSUMER. STATED, CONSUMER IS SEEING A CLEAR LIQUID WHEN PLUNGER IS PUSHED UP. STATED, WHEN CONSUMER FOUND THIS ISSUE, HE BOUGHT BOX BACK TO STORE FOR REPLACEMENT. PHARMACIST WAS ABLE TO DUPLICATE ISSUE BUT STATED, HE DOES NOT SEE IT WITH EVERY SYRINGE. SYRINGES FOUND WITH "CLEAR LIQUID" WERE NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9662467 ↗
• MalfunctionJan 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857, BATCH NO: UNKNOWN. VERBATIM: ISSUE: CONSUMER REPORTED NEEDLES ARE DULL, IT HURTS DURING THE INJECTION. HE CAN TELL THE NEEDLES ARE DULL LOOKING AT THE NEEDLE POINT. CONSUMER ALSO REPORTED THAT NEEDLE COMES OFF WITH THE HUB, WHEN HE REMOVES THE NEEDLE SHIELD. BOX DISCARDED, HE IS NOT HOME, HE THINKS HE HAS THROWN THE BOX. SAMPLE DISCARDED. HE USES THE .5ML, 31G, 8MM. SYRINGES. HE USES THE NEW NEEDLE EACH TIME OF HIS INJECTION. HE VISUALLY TEST THE NEEDLE TO SEE IF IT IS STRAIGHT. ITEM#928857 LOT# UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604384 ↗