The Recall Desk

Hazard

Device Damage recalls

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

What the numbers show

Total
37
Critical
1
Severe
11
Most recent
2024-04-24

Of the 37 device damage recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (30%) 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 device damage 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 37

  • HighFDA (Devices)·Z-1597-2024·2024-04-24

    RENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk

    Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.

    Product
    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1286-2024·2024-04-03

    Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures

    InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.

    Product
    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2022·2022-02-16

    Baxter peritoneal dialysis transfer sets may crack or leak with certain cleaners

    Baxter MiniCap Extended Life PD Transfer Sets may be damaged by certain cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents, potentially causing leaking or cracking. No injuries have been reported.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2610-2021·2021-10-06

    Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.

    Product
    Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0614-2021·2021-04-21

    Novo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Levemir FlexTouch insulin pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    LEVEMIR — LEVEMIR (INSULIN DETEMIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0619-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2021·2021-04-21

    Novo Nordisk Recalls Xultophy 100/3.6 Due to Temperature Abuse

    Novo Nordisk is recalling Xultophy 100/3.6 samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    XULTOPHY 100/3.6 — XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0621-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2021·2021-04-21

    Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

    Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0622-2021·2021-04-21

    Novo Nordisk Recalls Victoza Injection Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of Victoza (liraglutide) injection because they were stored below 32°F, potentially causing loss of efficacy and device damage.

    Product
    VICTOZA — VICTOZA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2021·2021-04-21

    Novo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse

    Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    SAXENDA — SAXENDA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1340-2021·2021-04-14

    Medtronic HVAD Battery Recall for Potential Controller Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1336-2021·2021-04-14

    Medtronic HVAD Controller Recall for Potential Port Damage

    Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1338-2021·2021-04-14

    Medtronic HVAD Alarm Adapter Recalled for Potential Port Damage

    Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.

    Product
    Medtronic HVAD Alarm Adapter, Product Number: 1450
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0561-2021·2020-12-16

    Medtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk

    Medtronic is recalling 19,961 Evolut PRO+ Transcatheter Aortic Valve systems due to a potential for leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2904-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2020·2020-05-06

    Uromedica Recalls ProACT Implantation Instrument Sets Due to Sheath Defects

    Uromedica Inc. is recalling 11 ProACT Implantation Instrument Sets because defective U-channel sheaths may damage ProACT implant devices during use.

    Product
    ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled Due to Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling 1,356 EQUISTREAM Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0995-2019·2019-03-20

    Steris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect

    Steris Corporation is recalling 11 AMSCO 3000 Series Washer/Disinfector units because a software defect may prevent intended processing cycles, risking inadequate cleaning or damage to medical instruments.

    Product
    AMSCO 3000 Series Washer/Disinfector Model # 3052
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-2359-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead Damage Risk

    FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.

    Product
    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2351-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.

    Product
    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2350-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead and Stylet Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2356-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2345-2018·2018-07-11

    FHC microTargeting Drive System Recalled for Lead Damage Risk

    FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2346-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS-01
    Category
    Medical Device
    Distribution
    46 states