Hazard

Under Delivery recalls

12 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 12
Critical: 0
Severe: 2
Most recent: 2026-07-08

Of the 12 under delivery recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (17%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all under delivery recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–12 of 12

SevereFDA (Devices)·Z-2603-2026·2026-07-08
Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.
Product
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1797-2026·2026-04-22
Omnipod 5 insulin pods from 49 lots have torn internal cannulas
Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.
Product
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2552-2021·2021-10-06
B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.
Product
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2553-2021·2021-10-06
B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery
B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.
Product
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2547-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk
B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.
Product
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2556-2021·2021-10-06
Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.
Product
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2546-2021·2021-10-06
Outlook Pump IV Sets Recalled for Leakage and Infection Risk
B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.
Product
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2021·2021-10-06
Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery
B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.
Product
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2549-2021·2021-10-06
Outlook Pump Measured Volume Solution Set recalled for cassette leakage
B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.
Product
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.
Product
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1918-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 25 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
Product
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1919-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.
Product
REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
Category
Medical Device
Distribution
44 states