Hazard

Separation recalls

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

What the numbers show

Total: 32
Critical: 0
Severe: 2
Most recent: 2025-03-12

Of the 32 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 2 (6%) 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 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.

1–25 of 32

HighFDA (Devices)·Z-1295-2025·2025-03-12
AURORA Surgiscope System Obturator May Break or Separate
Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.
Product
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1975-2024·2024-06-12
ADVANTA VXT vascular graft recalled for swivel rod separation
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.
Product
ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2811-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.
Product
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2804-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2807-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2803-2018·2018-08-22
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 separation between the female luer and manifold.
Product
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2805-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2814-2018·2018-08-22
ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
Product
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2812-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2809-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2806-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2816-2018·2018-08-22
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 separation between the luer and manifold.
Product
6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2810-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.
Product
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2800-2018·2018-08-22
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 separation between the female luer and the manifold.
Product
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1464-2017·2017-03-22
CareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports
CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.
Product
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1160-2017·2017-03-01
Biomet Oxford Knee Instruments Recalled for Material Inclusions
Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1153-2017·2017-03-01
Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System Femoral Slap Hammers due to potential alumina inclusions that could cause the instruments to crack or separate.
Product
Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1161-2017·2017-03-01
Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1156-2017·2017-03-01
Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1175-2017·2017-03-01
Biomet Oxford Knee Instruments Recalled for Material Inclusions
Biomet is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1159-2017·2017-03-01
Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1158-2017·2017-03-01
Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1157-2017·2017-03-01
Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1168-2017·2017-03-01
Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1170-2017·2017-03-01
Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 1 instruments due to potential alumina inclusions that could cause cracking and separation.
Product
Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Category
Medical Device
Distribution
14 states