BD™ Allergy Syringe 305536Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382903055364), received between Jan 10, 2018 and Nov 5, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614656 ↗
• MalfunctionOct 6, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML HAD RUST ON IT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY NURSES SAID A NEEDLE HAD VISIBLE RUST ON IT.

  Patient problems: Insufficient Information

  MAUDE report 15554302 ↗
• MalfunctionOct 6, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML CAME UNLABELED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING PROBLEMS WITH SYRINGES. THESE CAME UNLABELED.

  Patient problems: Insufficient Information

  MAUDE report 15554029 ↗
• MalfunctionAug 17, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE FREQUENTLY HAVE BOXES THAT ARE PRINTED ON THE OUTSIDE AS TREATMENT SYRINGES WHEN OPENED THE PACKS MAY BE PRINTED AS TREATMENT UPON OPENING THEY MAY BE TESTING SYRINGES AND VICE/ VERSA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242079 ↗
• MalfunctionMar 4, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PRIOR TO USE OF A BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML, THE NEEDLE PENETRATED THROUGH THE SHIELD. THE PATIENT REQUIRED A BANDAGE FOR A PUNCTURE WOUND AND SCRATCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A REGISTERED NURSE REPORTED THAT SHE RECEIVED A NEEDLE STICK FROM A BENT NEEDLE THAT CAME THROUGH THE SIDE OF THE SYRINGE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13668010 ↗
• MalfunctionFeb 24, 2022Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE BD¿ ALLERGY SYRINGE, AND GLUE WAS FOUND INSIDE THE CAP. THIS OCCURRED WITH 25 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE WAS DETACHED FROM SYRINGE. APPEARS TO BE GLUED INSIDE CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595880 ↗
• MalfunctionNov 9, 2021Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT 3 BD¿ ALLERGY SYRINGES HAD DIFFICULT PLUNGER MOVEMENT WHILE TRYING TO INJECT MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE REPORTER STATED THE SYRINGES PULL SERUM WITH NO PROBLEM, BUT WHEN INSERTED INTO THE SKIN, THE SYRINGE IS HORRENDOUSLY DIFFICULT TO INJECT. IT WILL INJECT FINE IF NOT INSERTED INTO THE SKIN (ONTO GAUZE OR A COTTON BALL). TRIED SEVERAL SYRINGES (3-4) AND ENCOUNTERED THE SAME ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780616 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED WHEN USING THE BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE THE TIP/LUER OF THE SYRINGE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE MEDICAL PROFESSIONAL REPORTED, "THE HEADS OF THE SYRINGE ARE FALLING/BREAKING OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12709960 ↗
• InjuryApr 5, 2019Material Twisted/Bent

  IT WAS REPORTED THAT WHEN RECAPPING THE NEEDLE OF A BD¿ SYRINGE IB 25 TRAY 1000, THE NEEDLE BENT AND PIERCED THROUGH THE SHIELD, RESULTED IN NEEDLE STICK INJURY. THE STAFF MEMBER UNDERWENT BLOOD WORK FOLLOWING FACILITY PROTOCOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO: 305536, BATCH NO: 8205752. IT WAS REPORTED THAT WHEN THE STAFF MEMBER WAS RECAPPING THE NEEDLE AFTER USE, THE NEEDLE BENT AND PIERCED THE SHIELD WHICH RESULTED IN A NEEDLE STICK INJURY. THE STAFF MEMBER UNDERWENT BLOOD WORK FOLLOWING FACILITY PROTOCOL. INFORMATION WAS RECEIVED ON FOLLOW UP CALL WITH CUSTOMER ON 03/27.¿

  Patient problems: Needle Stick/Puncture

  MAUDE report 8487397 ↗
• MalfunctionApr 5, 2019Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE NEEDLE OF TWO BD¿ SYRINGE IB 25 TRAY 1000 PIERCED THROUGH THE SHIELD. IT WAS ALSO REPORTED THAT WHEN REMOVING THE NEEDLE CAP, THE NEEDLE STUCK IN THE SHIELD, RESULTED IN SEPARATION OF NEEDLE AND SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ MATERIAL NO: 305536 BATCH NO: 8205752 IT WAS REPORTED THAT THERE WERE TWO OCCURRENCES WHEN RECAPPING THE NEEDLE, THE NEEDLE BENT AND PIERCED THE SHIELD. THERE WAS ALSO AN INSTANCE WHEN THE CAP WAS ATTEMPTING TO BE REMOVED BEFORE USE, THE NEEDLE STUCK IN THE SHIELD AND THE NEEDLE AND HUB SEPARATED FROM THE SYRINGE. INFORMATION WAS RECEIVED ON FOLLOW UP CALL WITH CUSTOMER ON (B)(6). ¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8487330 ↗
• MalfunctionAug 14, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SYRINGES IN THE BOX OF BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WERE IN QUESTION. THE LABEL ON BOXES DOES NOT MATCH THE PRODUCT INSIDE THE BOX. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781825 ↗
• MalfunctionJan 10, 2018Packaging Problem

  IT WAS REPORTED THAT THE LABEL OF A BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WITHOUT SAFETY WAS INCORRECT, AND STATED ¿TREATMENT¿ INSTEAD OF ¿TESTING¿ ON THE LABEL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180516 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4