Alaris 8975 (UDI 10885403897511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 10885403897511), received between Jan 11, 2018 and Dec 22, 2023 — classified as 5 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (121 reports).

35 other recalls cover devices cleared under the same FDA submission (K133532); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE INSULIN FLOW WILL STOP BEFORE THE COMPLETE DOSAGE IS DISPENSED ON 13 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN TAKING INJECTION THE INSULIN FLOW WILL STOP BEFORE THE COMPLETE DOSAGE IS DISPENSED. STATED, SHE HAS TO USE A SECOND PEN NEEDLES TO COMPLETE HER INJECTION. 13 PEN NEEDLES AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383568 ↗
• MalfunctionAug 21, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE BOX OF BD NANO¿ 2ND GEN PEN NEEDLE DID NOT HAVE EXPIRATION DATE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED FOUND IN HOME WITHOUT AN EXPERATION DATE ON BOX. AFTER OBTAINING THE LOT #, NDC # AND RX DATE ON THE BOX IT WAS DETERMINED THIS BOX IS EXPRIRED AND MANUFACTURED IN 2009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585661 ↗
• MalfunctionAug 4, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED BY THE CONSUMER THAT THE BD NANO¿ 2ND GEN PEN NEEDLE IS DIFFICULT TO DEPRESS. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITITAL REPORTER: VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, HE STATED THAT THE PEN IS DIFFICULT TO DEPRESS. CONSUMER DID NOT HAVE A PROBLEM WHILE PRIMING. CONSUMER DOES NOT RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466724 ↗
• MalfunctionAug 4, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED BY THE CONSUMER THAT THE BD NANO¿ 2ND GEN PEN NEEDLE CLOGGED DURING INJECTION. REPORT 1 OF 2. THE FOLLOWING WAS RECIEVED BY THE INITITAL REPORTER: VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, HE STATED THAT THE PEN IS DIFFICULT TO DEPRESS. CONSUMER DID NOT HAVE A PROBLEM WHILE PRIMING. CONSUMER DOES NOT RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466713 ↗
• MalfunctionMar 25, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM . CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS. STATED, WHEN HE TRIES A SECOND PEN NEEDLE, IT WILL WORK. 12 PEN NEEDLES AFFECTED. LOT: 7353668. CATALOG: 320883. DATE OF EVENT: UNKNOWN. SAMPLES: YES. PRODUCT IS EXPIRED CL. PRODUCT INFORMATION. PRODUCT LINE: USBD. BUSINESS UNIT: DIABETES CARE (DC). PRODUCT FAMILY: PEN NEEDLE. PRODUCT COMPONENT/ISSUE/LOT(S): PIR. PRODUCT NAME: PEN NEEDLE 32G. LOT NUMBER(S) AND/OR SERIAL NUMBER(S): (B)(6) MATERIAL/CATALOG NUMBER: 320883. QUANTITY INVOLVED: 12. CONTAMINATED: NO. USED PRODUCT TO BE RETURNED FOR EVALUATION: YES. HOW MANY UNITS?: 12. IS COUNTRY EVENT OCCURRED UNKNOWN: NO. COUNTRY EVENT OCCURRED: UNITED STATES OF AMERICA. REPRESENTATIVE SAMPLES?: NO. CURRENT LOCATION OF DEVICE: END USER. REPLACEMENT OR CREDITS FOR AFFECTED DEVICES?: REPLACEMENT. BD AWARENESS DATE: 2023-03-08. COMPLAINT DATE RECEIVED: 2023-03-08. ADVERSE EVENTS. WHEN DID THE INCIDENT OCCUR?: DURING USE DEATH?: NO. SERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616548 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED INJECTED INTO THIGH AND FOUND FLEXPEN WOULD NOT MOVE OR PRESS OUT INSULIN DURING INJECTING FOUND NEEDLE BROKE OFF AT SOMETIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519349 ↗
• MalfunctionMar 1, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G THE MEDICATION COULD NOT BE DELIVERED PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN PRIMING IS SUCCESSFUL AND SHE TAKES HER INJECTION, THE FLOW WILL STOP BEFORE SHE'S COMPLETED FULL DOSAGE SO SHE HAS TO USE A SECOND PEN NEEDLE TO COMPLETE INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464738 ↗
• MalfunctionFeb 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G IT COULD NOT BE PRIMED. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 4 PEN NEEDLES CLOGGED DURING FLOW CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399573 ↗
• MalfunctionDec 23, 2022No Flow; No Flow

  IT WAS REPORTED WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040885 ↗
• InjuryOct 20, 2022Break; Break

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLE BROKE OFF IN THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN THE INJECTION SITE

  Patient problems: Foreign Body In Patient

  MAUDE report 15643147 ↗
• MalfunctionOct 14, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO PEN NEEDLES WERE UNABLE TO PRIME, OR UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING NEEDLES THAT CLOG DURING FLOW CHECK; OTHERS JUST DURING INJECTION FROM THIS BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610685 ↗
• MalfunctionOct 11, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NANO PEN NEEDLE WAS UNABLE TO ATTACH TO THE PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE INSULIN PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584275 ↗
• InjuryAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLES BROKE OFF DURING INJECTION. THE PATIENT VISITED THE ER, WHERE TWEEZERS WERE USED TO REMOVE THE BROKEN PIECE, AND SUPER GLUE WAS USED TO SEAL THE SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED BD NANO 4MM PEN NEEDLE. STATED BROKE OFF IN SITE (B)(6) 2022 DURING INJECTING. CALLER STATED VISITED THE EMERGENCY ROOM AT LOCAL HOSPITAL. CONSUMER CALLED BACK. INFORMED THE ER USED TWEEZER TO REMOVE THE NEEDLE AND DID NOT COMPLETE XRAYS FOR THIS VISIT. THEY DID USE A SUPER GLUE AT THIS CALLERS SITE. CALLER DENIED REUSE OF NEEDLES. HE PLACED THE NEEDLE ASSEMBLY FROM THIS INCIDENT IN HIS SHARPS CONTAINER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15183061 ↗
• MalfunctionAug 8, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182290 ↗
• MalfunctionAug 4, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS CLOGGED WHILE PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163601 ↗
• MalfunctionApr 26, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214874 ↗
• MalfunctionApr 18, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AT LEAST 20 BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES WERE UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM A TYPE 2 DIABETIC. NEEDLE WAS UNUSABLE BECAUSE THE INSULIN DOES NOT PASS AND THOSE AT LEAST 20 TIMES ON A BOX.

  Patient problems: Insufficient Information

  MAUDE report 14138416 ↗
• MalfunctionApr 4, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ ULTRA-FINE¿ PEN NEEDLES WERE NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE PULL THE TAG OFF, THE NEEDLE IS UNABLE TO INSERT INTO PEN. WE'VE SEEN THIS ON SEVERAL NEEDLES IN THE LAST FEW BOXES WE'VE USED - THE FREQUENCY IS INCREASING ON THE CURRENT BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002732 ↗
• MalfunctionFeb 24, 2022Misconnection; Misconnection

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WOULD NOT FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, SOME PEN NEEDLES WILL NOT ATTACH TO INSULIN PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590618 ↗
• MalfunctionFeb 8, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT BD ULTRA-FINE¿ NANO¿ PEN NEEDLE EXPERIENCED TWO CASES OF BEING UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED SOME OF THE PEN NEEDLES WERE CLOGGED DURING FLOW CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481950 ↗
• MalfunctionFeb 3, 2022Problem with Sterilization; Packaging Problem; Problem with Sterilization; Packaging Problem

  IT WAS REPORTED THAT 4 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES EXPERIENCED DAMAGED UNIT PACKAGING WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED TEAR DROP LABELS MISSING PRIOR TO INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443809 ↗
• MalfunctionDec 8, 2021Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  IT WAS REPORTED THAT BD 4MM 32GA PEN NEEDLES EXPERIENCED 29 CASES OF BEING UNABLE TO DELIVER MEDICATION, AND 29 CASES OF NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING SEVERAL THAT CLOG DURING THE INJECTION. CONSUMER REPORTED THE NON PATIENT END FELT HARD TO PLACE ONTO THE PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961072 ↗
• MalfunctionDec 7, 2021Break; Failure to Deliver; Break; Failure to Deliver

  IT WAS REPORTED THAT THE BD 4MM PEN NEEDLE WAS NOT FUNCTIONING, AND HAD THE CANNULA BREAK OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MOST RECENT BOXES OF THESE NEEDLES HAVE NOT BEEN UP TO YOUR USUAL QUALITY . I THOUGHT IT WAS JUST A FLUKE, BUT THIS BOX I AM USING NOW HAS HAD SEVERAL NEEDLES THAT ARE DEFECTIVE AND DO NOT PIERCE THE PEN TO ALLOW THE INSULIN TO FLOW. UPON EXAMINATION THE NEEDLES WERE EITHER BENT ALL THE WAY OVER, OR NOT PRESENT AT ALL ON THE END THAT ATTACHES TO PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954668 ↗
• MalfunctionDec 3, 2021Failure to Deliver; Material Deformation; Failure to Deliver; Material Deformation

  IT WAS REPORTED THAT 1 BD NANO¿ ULTRA-FINE¿ PEN NEEDLE WAS DIFFICULT TO OPERATE AND THERE WERE 9 NEEDLES THAT WERE UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, USED BD NANO ULTRA-FINE PEN NEEDLES AND HAVE HAD 10 DEFECTIVE NEEDLES IN THIS SUPPLY LOT #0160115 EXP: 7-31-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929630 ↗
• MalfunctionNov 24, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED BD NANO ULTRA-FINE PEN NEEDLE WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...FINDS PEN NEEDLES TO BE CLOGGED DURING FLOW CHECK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133532. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2026 · Feb 11, 2026 · Open, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-1544-2021 · Mar 26, 2021 · Open, Classified
  Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
• Z-1651-2021 · Mar 25, 2021 · Open, Classified
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
• Z-1375-2021 · Mar 24, 2021 · Open, Classified
  Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
• Z-1309-2021 · Mar 3, 2021 · Open, Classified
  BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
• Z-1543-2021 · Feb 26, 2021 · Terminated
  Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
• Z-1332-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
• Z-2204-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
• Z-1331-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
• Z-2910-2020 · Aug 4, 2020 · Open, Classified
  PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
• Z-2882-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
• Z-2909-2020 · Aug 4, 2020 · Open, Classified
  Alaris System PC Unit Model 8015

…and 20 more.