Hazard

Assembly Defect recalls

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

What the numbers show

Total: 110
Critical: 0
Severe: 12
Most recent: 2026-07-01

Of the 110 assembly defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (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 assembly defect 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.

51–75 of 110

HighFDA (Devices)·Z-1976-2021·2021-07-07
Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly
Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.
Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1943-2021·2021-06-30
LED therapy device pads recalled for improper cord assembly and power failure risk
Inlightened Partners LLC is recalling 926 inLight Medical LED Pads due to improper assembly of cord connectors, which may cause power interruptions and controller shutdown.
Product
inLight Medical LED Pads used with Polychromatic light technology system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2021·2021-06-16
Atec Insignia Anterior Cervical Plate System Screw Blocking Mechanism Risk
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2021·2021-01-06
Intersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port
Intersurgical Inc is recalling 200 Smoothbore breathing systems with exhalation port 22 mm because they were assembled with the incorrect port, which can cause gas leakage.
Product
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhala
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0397-2019·2018-11-14
Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error
Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
Product
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2946-2018·2018-09-05
Civco Needle Guide Recall Due to Missing or Inadequate Adhesive
Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.
Product
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1390-2018·2018-04-25
NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect
Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.
Product
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0833-2018·2018-03-07
DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants
DePuy Orthopaedics is recalling 23,053 DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
Product
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0472-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0437-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Product
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced set screws and sleeves, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0429-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.
Product
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper installation.
Product
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Product
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0431-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0448-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0445-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0435-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the device from being properly assembled.
Product
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.
Product
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0467-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Product
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0451-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Product
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2018·2018-02-07
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
Product
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
Category
Medical Device
Distribution
Distributed nationwide