Hazard

Medication Leakage recalls

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

What the numbers show

Total: 18
Critical: 0
Severe: 2
Most recent: 2026-07-08

Of the 18 medication leakage 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 (11%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all medication leakage 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.

1–18 of 18

SevereFDA (Devices)·Z-2549-2026·2026-07-08
Hillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.
Product
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2548-2026·2026-07-08
Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.
Product
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2524-2025·2025-09-10
CADD yellow 100 mL reservoirs recalled over weakened medication bag welds
Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.
Product
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2525-2025·2025-09-10
Flow stop cassette reservoirs recalled because medication bag welds may weaken
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.
Product
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2523-2025·2025-09-10
Medication cassette reservoirs recalled over weakened bag welds causing leakage
Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2522-2025·2025-09-10
CADD 50 mL cassette reservoirs recalled over weakened bag welds
Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2526-2025·2025-09-10
CADD 100 mL flow stop reservoirs recalled over weakened bag welds
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.
Product
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2527-2025·2025-09-10
NRFit yellow cassette reservoirs recalled over weakened medication bag welds
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.
Product
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0253-2025·2025-03-12
Lorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
Safecor Health, LLC is recalling Lorazepam 0.5 mg oral syringes nationwide due to a defective delivery system that causes leakage after repackaging.
Product
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2025·2024-10-30
CADD Medication Cassette Reservoir weld defect poses leakage risk
Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.
Product
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0018-2025·2024-10-30
ENT Medication Reservoirs Recalled for Weakened Weld Joint
Smiths Medical is recalling certain ENT medication reservoirs due to weakened weld joints that may cause medication leakage. Approximately 120,960 units are affected and distributed worldwide.
Product
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0013-2025·2024-10-30
CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0016-2025·2024-10-30
CADD Medication Cassette Reservoir Recall Due to Defective Weld Joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs with defective weld joints that may cause medication leakage. The issue affects 8,976 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0017-2025·2024-10-30
Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
Product
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0015-2025·2024-10-30
CADD Medication Cassette Reservoir recalled for weakened weld joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.
Product
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0012-2025·2024-10-30
CADD Medication Cassette Reservoir recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs (100mL) due to a production equipment malfunction that may weaken the weld joint between the medication bag and tubing, potentially causing medication leakage. The recall affects 26,160 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0011-2025·2024-10-30
CADD Medication Cassette Reservoir Recalled for Weld Defect Risk
Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.
Product
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0010-2025·2024-10-30
CADD Medication Cassette Reservoirs recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.
Product
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Category
Medical Device
Distribution
0 states