The Recall Desk

Hazard

Assembly Error recalls

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

What the numbers show

Total
39
Critical
0
Severe
6
Most recent
2025-12-17

Of the 39 assembly error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (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 assembly error 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.

26–39 of 39

  • HighFDA (Devices)·Z-0105-2019·2018-10-24

    Liko Multirall 200Liko Strap Gripper Overhead Lift Recall

    Liko AB is recalling two Multirall 200Liko Strap Gripper overhead lifts due to potential assembly errors that could cause patient falls.

    Product
    Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2496-2018·2018-07-25

    Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect

    Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.

    Product
    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2017·2017-05-24

    Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error

    Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.

    Product
    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1769-2017·2017-04-19

    Datascope Recalls Custom Tubing Packs Due to Assembly Error

    Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.

    Product
    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterili
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1029-2016·2016-03-09

    Argon Medical Devices Recalls ClosureFast Introducer Sheath Sets Due to Assembly Error

    Argon Medical Devices is recalling specific ClosureFast Introducer Sheath Sets because incorrect sheath lengths were assembled to the devices.

    Product
    ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2072-2015·2015-07-22

    Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error

    Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.

    Product
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1815-2015·2015-06-24

    Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.

    Product
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2015·2014-11-26

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Assembly Error

    Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.

    Product
    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1126-2014·2014-03-12

    Hospira Recalls LifeShield Blood Sets Due to Assembly Errors

    Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.

    Product
    *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2014·2014-03-05

    GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2013·2013-10-02

    Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error

    Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.

    Product
    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V439000·2013-09-18

    Navistar Recalls 2008-2013 International Trucks Due to Air Line Assembly Error

    Navistar is recalling 2008-2013 International LoneStar, ProStar, and TranStar trucks because an assembly error in the air lines may cause the fifth wheel jaw to release unexpectedly, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL TRANSTAR, LONESTAR, PROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2013·2012-11-28

    Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error

    Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.

    Product
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0008-2013·2012-10-10

    Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error

    Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.

    Product
    Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950,
    Category
    Medical Device
    Distribution
    Distributed nationwide