The Recall Desk

Hazard

Device Disassembly recalls

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

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2025-05-14

Of the 8 device disassembly recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device disassembly 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.

1–8 of 8

  • SevereFDA (Devices)·Z-1717-2025·2025-05-14

    CODMAN Craniotomy Kit Cranial Perforator Disposed Over Weld Defect

    Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.

    Product
    CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1688-2024·2024-05-01

    PIEZON Bottle May Disassemble Under Pressure During Dental Use

    FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.

    Product
    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2023·2023-05-10

    CryoTreQ Aa ophthalmic instrument recalled for risk of sudden disassembly

    Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.

    Product
    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2023·2023-05-03

    Lateral lumbar spine implant plate may disassemble during surgery

    SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.

    Product
    JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2020·2020-08-05

    Medline Recalls ClearPro T-Piece Closed Suction Catheters Due to Assembly Failure

    Medline Industries is recalling 2,440 units of ClearPro T-Piece Closed Suction Catheters because reports indicate the catheter may come apart from the device assembly during use.

    Product
    ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2014·2013-11-27

    Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld

    Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.

    Product
    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide