Hazard

Component Separation recalls

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

What the numbers show

Total: 138
Critical: 0
Severe: 21
Most recent: 2025-04-24

Of the 138 component separation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (15%) 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 separation 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.

101–125 of 138

HighFDA (Devices)·Z-2798-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2802-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2808-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.
Product
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2813-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2797-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2815-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2801-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
Product
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2040-2018·2018-06-06
Torax Medical Recalls LINX Reflux Management System Devices
Torax Medical is recalling LINX Reflux Management Systems because a bead component may separate from an adjacent wire link, potentially resulting in a discontinuous or open device.
Product
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Lapa
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18E038000·2018-05-31
Yakima HoldUp Evo Hitch Bike Racks Recalled for Rear Tray Separation
Yakima is recalling HoldUp Evo hitch-mounted bike racks because the rear tire tray may separate while driving, increasing crash risk.
Product
EQUIPMENT recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0021-2018·2017-11-01
OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation
OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.
Product
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3072-2017·2017-09-06
Medspira mcompass Balloon Catheters Recalled for Potential Separation
Medspira is recalling mcompass 2-channel Balloon Catheters because the balloon may separate from the inner stem and remain in the rectal cavity.
Product
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate a
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1201-2017·2017-02-22
Terumo Recalls Hercules 360 Universal Stabilizing Arms Due to Pin Separation
Terumo CVS is recalling Hercules 360 Universal Stabilizing Arms because pins may come loose and fall into the surgical site.
Product
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0653-2017·2016-11-30
AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk
AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.
Product
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when con
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-2608-2016·2016-08-31
Richard Wolf Conical Portio Adapter Recall Due to Weld Defect
Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters because an improper weld may cause the device to separate during use.
Product
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2586-2016·2016-08-24
Synthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk
Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.
Product
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficie
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16E056000·2016-06-13
Wilson Manifolds Recalls Peter Paul Nitrous Solenoid Valves
Wilson Manifolds is recalling specific Peter Paul 22X01031GM 12/DC solenoid valves due to improper welding that may cause the piston to eject under pressure.
Product
FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2016·2016-06-01
Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.
Product
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0588-2016·2016-01-13
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
Product
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of ca
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0421-2016·2015-12-23
Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk
Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.
Product
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2795-2015·2015-09-30
Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk
Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.
Product
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2143-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation 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 RP PS ARTICULATION SURFACE SZ1-9 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-2146-2015·2015-07-29
DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation 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 TB TRL SZ3 - 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 Surface to
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2084-2015·2015-07-22
NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect
Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.
Product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1943-2015·2015-07-08
US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect
US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.
Product
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange,
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·15V427000·2015-07-06
Harley-Davidson Recalls 2014-2015 Motorcycles Due to Saddlebag Mounting Defect
Harley-Davidson is recalling approximately 185,272 model year 2014-2015 motorcycles because saddlebag mounting receptacles may not adequately secure the saddlebags, creating a road hazard.
Product
HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHXSE, FLHP, FLHR, FLHTCU
Category
Vehicle
Distribution
Distributed nationwide