Hazard

Device Leakage recalls

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

What the numbers show

Total: 17
Critical: 0
Severe: 7
Most recent: 2026-07-22

Of the 17 device 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 7 (41%) 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 device 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.

1–17 of 17

SevereFDA (Devices)·Z-2681-2026·2026-07-22
ABIOMED Impella RP Flex heart pump introducer sheath leakage risk
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2682-2026·2026-07-22
ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2687-2026·2026-07-22
ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
Product
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2678-2026·2026-07-22
Abiomed Impella Introducer Kit Recalled Due to Potential Leakage
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
Product
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2688-2026·2026-07-22
Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Product
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2683-2026·2026-07-22
ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2580-2026·2026-07-01
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.
Product
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2024·2024-07-17
Cardiovascular Procedure Kits Recalled for Potential Syringe Design Defects
Cardinal Health recalls 17,445 cardiovascular procedure kits nationwide containing potentially defective syringes that could cause inaccurate dosing or device leakage.
Product
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2024·2024-07-17
Presource surgical kits recalled for syringe design defect risk
Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.
Product
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2024·2024-07-17
Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.
Product
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2024·2024-07-17
Presource Neurological Surgical Kits Recalled for Syringe Design Defect
Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.
Product
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0940-2024·2024-02-07
Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Product
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2024·2023-11-15
Allergan Universal Fill Kit for tissue expanders recalled due to leakage risk
B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.
Product
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2022·2022-04-20
Abbott Vascular 20/30 Indeflator Recalled for Leaks and Connection Failures
Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.
Product
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2022·2022-02-16
Baxter PD Transfer Set Recall: Risk of Leaking or Cracking
Baxter recalls 62,712 MiniCap Extended Life PD Transfer Sets worldwide due to potential damage from certain cleaning products. Exposure to products containing bleach, hydrogen peroxide, or solvents may cause leaking or cracking.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0457-2022·2022-01-12
Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
Product
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Category
Medical Device
Distribution
41 states
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