Walgreens 654882Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00311917048154), received between Apr 4, 2018 and Apr 18, 2024 — classified as 3 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (32 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material

  PET OWNER REPORTED SHE IS SEEING A "CLEAR LIQUID" IN BARREL PRIOR TO INJECTION. STATED, WHEN SHE PUSHES ON PLUNGER, THE LIQUID COMES OUT ONTO THE NEEDLE. LOT: UNKNOWN. CATALOG: 928858. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130885 ↗
• MalfunctionMar 3, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 80 WALGREENS THIN INSULIN SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SCALE MARKINGS ARE TILTED AND NOT STRAIGHT ON MOST ALL FROM THIS BOX. COUNTED 80 SYRINGE. USING ON DOG WITH SMALL AMOUNTS OF INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664362 ↗
• MalfunctionNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT WHEN REMOVING THE NEEDLE SHIELD PRIOR TO INJECTION, THE NEEDLE HUB SEPARATED AND WAS UNABLE TO USE THE SYRINGE. 1 SYRINGE WAS AFFECTED. DATE OF EVENT: (B)(6) 2021. SAMPLE: AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824172 ↗
• MalfunctionAug 20, 2021Leak/Splash; Delivered as Unsterile Product; Leak/Splash; Delivered as Unsterile Product

  IT WAS REPORTED THAT 2 BD SYRINGE 0.3ML 31G 8MM HAD SHIELD STERILITY AND FAILURE TO CONTAIN MEDICATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER STATED THAT THE PLUNGER CAP WAS BROKEN PRIOR TO USE AND THE BARREL WAS BROKEN OR CRACKED PRIOR TO USE. DATE OF EVENT: (B)(6) 2021. SAMPLE: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351389 ↗
• MalfunctionJul 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM HUBS SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE HUB WAS STUCK IN THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207338 ↗
• MalfunctionJul 1, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 2 BD¿ INSULIN SYRINGES FAILED TO ASPIRATE INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, NEEDLE WOULD NOT DRAW INSULIN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104396 ↗
• MalfunctionJul 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT 1 SYRINGE 0.3ML 31GA 8MM HUB SEPARATED. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104285 ↗
• MalfunctionMay 18, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 2 BD¿ INSULIN SYRINGES WOULD NOT DRAW UP INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 2 SYRINGES THAT WOULD NOT DRAW UP INSULIN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842978 ↗
• MalfunctionMay 17, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A CARTON OF SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: 'IT WAS REPORTED THAT EXPIRATION DATE WAS NOT ON SHELF CARTON. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT EXPIRATION DATE ON (B)(6) SYRINGES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11834577 ↗
• MalfunctionApr 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 7 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 7 SYRINGES FROM THIS BOX NEEDLE HUB STUCK IN SHIELD LOT # 0006883. CATALOG# 928857. DATE OF EVENT (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742394 ↗
• MalfunctionApr 23, 2021Failure to Deliver; Device Contamination with Chemical or Other Material; Failure to Deliver; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD FOREIGN MATTER (1) AND WAS DIFFICULT TO ASPIRATE (1) DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A SMALL AMOUNT OF CLEAR LIQUID CAME OUT OF THE SYRINGE WHEN THE CONSUMER PUSHED THE PLUNGER. ALSO, THE CONSUMER FOUND ONE SYRINGE WITH A CRUSHED NEEDLE SHIELD AND THE SYRINGE WOULD DRAW INSULIN. VERBATIM: CONSUMER DID NOT PROVIDE A PHONE NUMBER OR ADDRESS. (B)(6) CONSUMER REPORTED, WHEN SHE PUSHED ON THE PLUNGER, A SMALL AMOUNT OF CLEAR LIQUID CAME OUT CONSUMER DID NOT USE SYRINGE STATED, PRIOR TO USE, SHE FOUND ONE SYRINGE WITH A CRUSHED NEEDLE SHIELD STATED, 1 SYRINGE WOULD NOT DRAW INSULIN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721033 ↗
• MalfunctionApr 18, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG WOULD NOT ASPIRATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLES WILL NOT DRAW. CONSUMER DOES NOT RE-USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683261 ↗
• MalfunctionApr 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN REMOVING SHIELD WITH A BD INSULIN SYRINGE, 3/10ML 31G X 8MM THE HUB SEPARATED FROM DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED WHEN SHIELD WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672663 ↗
• MalfunctionApr 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ON ONE SYRINGE THE NEEDLE ASSEMBLY REMOVED WHEN THE SHIELD WAS REMOVED. VERBATIM: CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED SHIELD FROM SYRINGE THE NEEDLE ASSEMBLY REMOVED WITH IT. NO DIFFICULTIES REMOVING THE SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668101 ↗
• MalfunctionApr 9, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER REQUESTED INFORMATION ON THE EXPIRATION DATE. VERBATIM: CONSUMER REQUESTED INFORMATION ON EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646354 ↗
• MalfunctionMar 28, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG WAS UNABLE TO DRAW UP INSULIN. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928858 BATCH NO. 0125322. IT WAS REPORTED THAT SYRINGES WOULD NOT DRAW UP INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580289 ↗
• MalfunctionMar 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928858 BATCH NO: 0174605.   IT WAS REPORTED THAT A CONSUMER REPORTED SEEING CLEAR LIQUID IN SYRINGE PRIOR TO USE.   VERBATIM: WALGREENS CONSUMER REPORTED SEEING CLEAR LIQUID IN SYRINGE PRIOR TO USE. STATED, SHE PUSHED ON THE PLUNGER ROD AND CLEAR LIQUID. STATED, DOESN'T FEEL COMFORTABLE CONTINUING TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566204 ↗
• MalfunctionMar 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG EXPERIENCED 12 CASES OF HUB SEPARATION FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER STATED ABOUT 12 SYRINGES ARE DAMAGED. STATED THE NEEDLES ARE COMPLETELY MISSING FROM THE SYRINGES. LOT # 8186550 CAT # 928858 DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508075 ↗
• InjuryMar 11, 2021Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT 4 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD THE FOLLOWING PROBLEMS DURING USE. HUB SEPARATES (2), UNABLE TO ASPIRATE (2). THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ON 2 SYRINGES THE NEEDLE HUB SEPARATED INTO SHIELD. ALSO REPORTED 2 OTHER SYRINGES WOULD NOT DRAW UP INSULIN. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WHEN REMOVED NEEDLE SHIELD, THE NEEDLE HUB WENT WITH IT. CONSUMER REPORTED FOUND 2 OTHER SYRINGES FROM THIS BOX WHEN DREW UP INSULIN FROM VIAL, IT WOULD NOT DRAW UP THE INSULIN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468117 ↗
• MalfunctionJan 8, 2021Break; Failure to Deliver; Break; Failure to Deliver

  IT WAS REPORTED THAT WHILE USING BD INSULIN SYRINGE, 3/10ML 31G X 8MM THE PLUNGER WAS DIFFICULT TO MOVE AND CANNULA BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI WE HAVE A PATIENT THAT USES OUR INSULIN SYRINGES WIC 654882 NDC 11917-0048-15. THEY HAVE HAD ABOUT 2-5 IN EACH OF THE LAST COUPLE OF BOXES THAT HAVE BEEN DEFECTIVE. THE PLUNGER DID NOT WORK, THE NEEDLES BROKE WERE THE COMMON COMPLAINTS. THEY ARE GOING TO BRING A COUPLE IN IF YOU WOULD LIKE TO INVESTIGATE THEM. HOWEVER, THIS DOES NOT SEEM TO REFLECT HIGH QUALITY AS ADVERTISED.

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

  MAUDE report 11140998 ↗
• MalfunctionJan 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 10 SYRINGE 0.3ML 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. VERBATIM: (B)(6) CONSUMER REPORTED NEEDLE HUB SEPARATION WITH 10 SYRINGES FROM CURRENT BOX. STATED SHE REMOVED THE ORANGE CAP AND THE WHOLE NEEDLE COMPONENT COMES OFF WITH THE CAP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11127899 ↗
• MalfunctionJan 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 8 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED 8 SYRINGES REMOVED SHIELD AND NEEDLE HUB STAYED WITHIN THE SHIELD. VERBATIM: CONSUMER REPORTED FOUND 8 SYRINGES REMOVED SHIELD AND NEEDLE HUB STAYED WITHIN THE SHIELD".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11103533 ↗
• MalfunctionDec 30, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:928858, BATCH NO: 0006883, UNKNOWN. IT WAS REPORTED THAT THE SHIELDS ARE HARD TO REMOVE AND THE NEEDLE HUB STAYS IN THE SHIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11096140 ↗
• MalfunctionDec 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 7 SYRINGE 0.3ML 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 WHEN REMOVING SHIELD. VERBATIM: FROM PHONE CALL ON 2020-11-30 17:21:40: . LOT: 9324122. CATALOG: 928858. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL. FROM PHONE CALL ON 2020-11-30 17:19:04: CONSUMER STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. 7 SYRINGES AFFECTED CL. RECEIVED VOICEMAIL FROM WALGREENS CONSUMER STATING, 7 SYRINGES DID NOT WORK. RETURNED CALL CL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11083473 ↗
• MalfunctionDec 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 40 SYRINGES 0.3ML 31GA 8MM 10BAG 500 PL/WG HAD ISSUES WITH THE NEEDLE HUB SEPARATING INTO THE CAP WHEN REMOVING IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 11TH OF 14 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REP REPORTED ABOUT 40 SYRINGES IN CONSUMER'S BOX HAD AN ISSUE. STATED WHEN REMOVING THE ORANGE CAP THE WHOLE NEEDLE COMPONENT CAME OFF WITH THE CAP. REP IS REPORTING OF BEHALF OF CONSUMER."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11051536 ↗