Hazard

Component Detachment recalls

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

What the numbers show

Total: 189
Critical: 0
Severe: 57
Most recent: 2026-08-19

Of the 189 component detachment recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 57 (30%) 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 component detachment 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.

151–175 of 189

HighFDA (Devices)·Z-0251-2018·2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0248-2018·2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0240-2018·2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.
Product
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0243-2018·2017-12-20
Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect
Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.
Product
XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intrav
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0250-2018·2017-12-20
Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment
Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.
Product
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1497-2017·2017-04-05
Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk
Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.
Product
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or art
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1001-2017·2017-01-18
Siemens Biograph mCT Flow Edge-4R Scanner Recall for Laser Cover Windows
Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.
Product
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2017·2016-12-28
Oscor Recalls Medtronic Arrive Braided Transseptal Sheaths Due to Liner Fragmentation
Oscor, Inc. is recalling 991 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0773-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Component Defect
AngioDynamics is recalling 80 boxes of Stiffened Micro-Introducer Kits because a component may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0778-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 4F Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches from the hub during use.
Product
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 996 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0774-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 751 Stiffened Micro-Introducer Kits because a component may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0794-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 991 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0777-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 7 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach from the hub during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0776-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 145 boxes of Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H7
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0772-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H7870659
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0127-2017·2016-10-26
X Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices
X Spine Systems is recalling 1,186 Calix T PEEK Lumbar System trial devices because components may detach and lodge in the intervertebral space during surgery.
Product
Calix T PEEK Lumbar System, TLIF Trial
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1363-2016·2016-04-20
Natus Medical Recalls Medix NatalCare ST-LX Neonatal Incubators
Natus Medical is recalling Medix NatalCare ST-LX neonatal incubators because defective hinge assemblies may cause ports to detach.
Product
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·15V634000·2015-10-08
Volvo Recalls VNL Trucks Due to APU Mounting Defect
Volvo is recalling 2012-2014 VNL trucks because Electric Auxiliary Power Units may detach, creating a road hazard and increasing crash risk.
Product
VOLVO — VOLVO VNL
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·15V544000·2015-08-31
Micro Bird Recalls 2013-2015 G5 Transit Buses for Battery Fire Risk
Micro Bird is recalling 2013-2015 G5 transit buses because corroded battery studs may cause short circuits and fires, or missing bolts may cause battery detachment.
Product
MICRO BIRD — MICRO BIRD G5 TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2137-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2142-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2145-2015·2015-07-29
DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2140-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient.
Product
ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2139-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
Product
ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
Category
Medical Device
Distribution
51 states