The Recall Desk

Hazard

Fragmentation recalls

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

What the numbers show

Total
18
Critical
1
Severe
5
Most recent
2026-03-04

Of the 18 fragmentation recalls we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (28%) 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 fragmentation 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.

1–18 of 18

  • HighNHTSA·24V850000·2024-11-08

    2024-2025 Ford Escape: Passenger Airbag Cover Defect Recall

    Ford is recalling 2024-2025 Escape vehicles with a defective passenger airbag cover that may prevent proper deployment, increasing injury risk and failing to meet federal safety standards.

    Product
    FORD — FORD ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2025·2024-10-16

    Gelato Ice Cream Recalled for Possible Container Fragmentation

    ALCAS USA CORP. is recalling gelato ice cream packaged in compostable tubs due to possible fragmentation of the container material. Affected products were distributed in the USA, Cayman Islands, and Canada.

    Product
    Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/ 500 CC (M) (16.90 fl. oz.) COMPOSTABLE YETI TUB 500 Gr/750 CC (25.36 fl. oz.)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1547-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled for Breaking During Use

    Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2024·2024-05-29

    Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage

    Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.

    Product
    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2023·2023-06-14

    Surgical Anchor Inserter Tip Fragmentation During Patient Procedures

    DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2023·2023-06-14

    DePuy Mitek surgical anchor inserter tip may fragment and be retained

    DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2021·2021-02-17

    Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect

    Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.

    Product
    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2060-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Open Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2020·2019-10-30

    Medline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk

    Medline Industries is recalling Semi-Rigid Suction Canisters because the lids may fragment during use, posing a risk to patients and healthcare workers.

    Product
    Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1757-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1756-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 34 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0811-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0790-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 156 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighCPSC·85065·1985-12-10

    Clacker Ball Toys Seized for Shattering and Breaking During Use

    The CPSC announced the seizure of nearly 4,600 'Ker-Bangers' clacker ball toys in Phoenix. The toys are recalled because the plastic balls shatter or crack and handles break during use.

    Product
    clacker ball toy balls
    Category
    Consumer Product
    Distribution
    Distributed nationwide