The Recall Desk

Hazard

Adverse Event recalls

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

What the numbers show

Total
21
Critical
0
Severe
6
Most recent
2026-02-25

Of the 21 adverse event 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 (29%) 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 adverse event 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.

1–21 of 21

  • SevereFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Over Adverse Events

    Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Due to Adverse Events

    Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1349-2022·2022-07-20

    CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports

    Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.

    Product
    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-0767-2019·2019-02-06

    West Pharma Vial2BAG DC 13mm Recalled for Adverse Events

    West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.

    Product
    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0769-2019·2019-02-06

    West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices

    West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model used with oxytocin in pregnant women.

    Product
    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0768-2019·2019-02-06

    FDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events

    West Pharma Services is recalling Vial2BAG Transfer Devices because adverse events were reported when used with oxytocin in pregnant women.

    Product
    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0945-2017·2017-01-11

    Smith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events

    Smith & Nephew is recalling Modular SMF and Modular REDAPT Hip Systems due to a higher-than-anticipated trend in complaints and adverse events.

    Product
    Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2017·2017-01-11

    Smith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events

    Smith & Nephew is recalling 13,671 modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2017·2017-01-11

    Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events

    Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2014·2013-12-18

    Arrow Transradial Artery Access Products Recalled for Occluded Needles

    Arrow International Inc is recalling Transradial Artery Access products because introducer needles may be occluded, posing a risk of delayed treatment or adverse events.

    Product
    Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-417-2013·2013-05-22

    NuVision Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    NuVision Pharmacy is recalling 32 vials of Methylcobalamin Injection due to lack of assurance of sterility and reports of adverse events.

    Product
    Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0781-2013·2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2013·2013-02-13

    Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk

    Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2422-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 1,536 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2419-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2420-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends

    Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2424-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2423-2012·2012-09-26

    Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2421-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state