FDA Device Recall Reports Sample

Source Files For 20260907135529-a7cd5d0f3305

• recall.json: source

Open Data Contract YAML

Open raw YAML

dataset_id: fda-device-recalls
title: FDA Device Recall Reports Sample
description: FDA Device Recall Reports Sample discovered from api.fda.gov. Bounded
  source query (limit=100); completeness is not assumed.
source_name: api.fda.gov
source_url: https://api.fda.gov/device/recall.json?limit=100
update_frequency: daily
next_scan_at: '2026-09-07T17:55:31.622621+00:00'
license:
  name: U.S. Food and Drug Administration website policy
  url: https://www.fda.gov/about-fda/about-website/website-policies
tags:
- api.fda.gov
geography:
- United States
revisions:
- revision_id: 20260907135529-a7cd5d0f3305
  detected_at: '2026-09-07T13:55:29+00:00'
  source_updated_at: null
  context: recall.json detected from recall.json.
  assets:
  - asset_id: asset-d7351bbcbb39cb42
    name: recall.json
    source_url: https://api.fda.gov/device/recall.json?limit=100
    media_type: application/json; charset=utf-8
    content_hash: d7351bbcbb39cb42bfae873fb6cccc2cf5d72d115d3624525328258d7ffba040
    size_bytes: 3238658
    parent_archive_id: null
  row_count: 100
  headers:
  - action
  - additional_info_contact
  - address_1
  - address_2
  - cfres_id
  - city
  - code_info
  - country
  - distribution_pattern
  - event_date_created
  - event_date_initiated
  - event_date_posted
  - event_date_terminated
  - firm_fei_number
  - k_numbers
  - openfda
  - pma_numbers
  - postal_code
  - product_code
  - product_description
  - product_quantity
  - product_res_number
  - reason_for_recall
  - recall_status
  - recalling_firm
  - res_event_number
  - root_cause_description
  - state
  sample_rows:
  - cfres_id: '30043'
    product_res_number: Z-0001-04
    event_date_initiated: '2003-10-27'
    event_date_posted: '2003-10-29'
    recall_status: Terminated
    event_date_terminated: '2004-03-24'
    res_event_number: '27549'
    product_code: IZL--
    k_numbers:
    - K020436
    product_description: Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by
      SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
    code_info: 'serial #PK10058'
    firm_fei_number: '1000139935'
    recalling_firm: Sedecal USA, Inc
    address_1: 2910 N Arlington Heights Rd
    city: Arlington Heights
    state: IL
    postal_code: 60004-1551
    additional_info_contact: "Mr. Devan Moser \n847-394-6960"
    reason_for_recall: A minimum source-skin-distance of less than 30 cm and not identifying
      the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable
      Systems not complying with the U.S. Federal performance standard.
    root_cause_description: Other
    action: An 'Important Safety Notice' dated 10/27/03 was sent to the one direct
      account on the same date, informing them of the non-compliances with the performance
      standard and requesting them to call Sedecal at 800-920-9525 to arrange for
      the modification of the x-ray unit at no cost to the user.
    product_quantity: 1 unit
    distribution_pattern: Vermont
    openfda: {}
  - cfres_id: '34578'
    product_res_number: Z-0001-05
    event_date_initiated: '2004-07-08'
    event_date_posted: '2004-10-05'
    recall_status: Terminated
    event_date_terminated: '2004-10-05'
    res_event_number: '29815'
    product_code: MGQ
    product_description: 'Aquasorb  Border, Hydrogel Wound Dressing with Polyurethane
      Film Border, 25 individual packets per case, Catalog # 46-511, 2.5'' x 2.5'',
      labeled in part ***Sterile***Manufacturer:  DeRoyal   200 Debusk Lane  Powell,
      TN  37849 USA***'
    code_info: Lot 360025
    firm_fei_number: '1000123222'
    recalling_firm: DeRoyal Wound Care
    address_1: Highway 58
    address_2: PO Box 309
    city: Rose Hill
    state: VA
    postal_code: 24281-0309
    additional_info_contact: 'Gracie Greenway

      865-362-1025'
    reason_for_recall: Wound dressing failed to meet sterility specifications.
    root_cause_description: Other
    action: DeRoyal Wound Care put a hold on remaining lot in inventory pending acceptable
      dose audit results. The recalling firm notified distributors by phone and letter
      on 7/8/04 and 7/13/04. The notification advised that the product be segregated
      to prevent further use and that distributors extend the recall to their consignees
      if product had been distributed.
    product_quantity: 4 cases
    distribution_pattern: Product was sold to 3 distributors in CA, OH and PA.
    openfda:
      k_number:
      - K990178
      - K943910
      - K981150
      - K952775
      - K962513
      - K984370
      - K953669
      - K010583
      - K983362
      - K952247
      - K992074
      - K962851
      - K024054
      - K983042
      - K945313
      - K935203
      - K964468
      - K942798
      - K990180
      - K913344
      - K040019
      - K952774
      - K982306
      - K945835
      - K961316
      - K965005
      - K951862
      - K973722
      - K934267
      - K944333
      - K920050
      - K962160
      - K982825
      - K980132
      - K984264
      - K002666
      - K973693
      - K961930
      - K952938
      - K971918
      - K945217
      - K990179
      - K953816
      - K982804
      - K970693
      - K984082
      - K964240
      - K943073
      - K940814
      - K003396
      - K991755
      - K915001
      - K960686
      - K954664
      - K943728
      - K982577
      - K933328
      - K991202
      - K926353
      - K922815
      - K000519
      - K932101
      - K945005
      - K984267
      - K950934
      - K953853
      - K973721
      - K041268
      - K921810
      - K952276
      - K083024
      - K002078
      - K932291
      - K953450
      - K964620
      - K942419
      - K930560
      - K941339
      - K040517
      - K984368
      - K961766
      - K963004
      - K961085
      - K955575
      - K955400
      - K954741
      - K952419
      - K911550
      - K961758
      - K984262
      - K024367
      - K951861
      - K980861
      - K973806
      - K973724
      - K022587
      - K920642
      - K990440
      - K965143
      - K984266
      - K914746
      - K022584
      - K961067
      - K964241
      - K013525
      - K946030
      - K935096
      - K974251
      - K993119
      - K000518
      - K984413
      - K926389
      - K940409
      - K951417
      - K041342
      - K171879
      - K962089
      - K933495
      - K920554
      - K915002
      - K973725
      - K943470
      - K954384
      - K946031
      - K970133
      - K011994
      - K990368
      - K020325
      - K932263
      - K970153
      - K960428
      - K912667
      - K962218
      - K962917
      - K970453
      - K980097
      - K953505
      - K002129
      - K944427
      - K932973
      - K980962
      - K002077
      - K022995
      - K962439
      - K933817
      registration_number:
      - '2029275'
      - '3010287685'
      - '3023548698'
      - '8044046'
      - '3009882464'
      - '9610694'
      - '2132242'
      - '3031168520'
      - '3015528146'
      - '3013298431'
      - '3016807311'
      - '3005488444'
      - '3012979524'
      - '1054241'
      - '9610200'
      - '1419520'
      - '3012535730'
      - '3011276993'
      - '3013557562'
      - '3006784948'
      - '2320762'
      - '1423537'
      - '3016096134'
      - '1061124'
      - '2125337'
      - '3012263097'
      - '1036836'
      - '3003636207'
      - '1034876'
      - '3014579161'
      - '2135152'
      - '1018120'
      - '1063707'
      - '1649690'
      - '3005465238'
      - '9680143'
      - '1646434'
      - '3024971708'
      - '1649518'
      - '3010143501'
      - '3006052875'
      - '9680091'
      - '1219103'
      - '1921846'
      - '3008770963'
      - '3005689226'
      - '1417592'
      - '1043214'
      - '1055236'
      - '3007048057'
      - '3010315629'
      - '1058584'
      fei_number:
      - '3010287685'
      - '3023548698'
      - '3009882464'
      - '3002806830'
      - '3031168520'
      - '1000112968'
      - '3015528146'
      - '3013298431'
      - '3016807311'
      - '3005488444'
      - '3012979524'
      - '1000143837'
      - '1419520'
      - '3012535730'
      - '3011276993'
      - '3013557562'
      - '1000138377'
      - '3006784948'
      - '3008162665'
      - '3016096134'
      - '2125337'
      - '3012263097'
      - '1036836'
      - '3003636207'
      - '1034876'
      - '3014579161'
      - '1000219637'
      - '1018120'
      - '1000512168'
      - '3005465238'
      - '1000306431'
      - '3001236277'
      - '3024971708'
      - '3002806986'
      - '3010143501'
      - '3006052875'
      - '1921846'
      - '3003040625'
      - '3008770963'
      - '1000148701'
      - '3005689226'
      - '1417592'
      - '1043214'
      - '3007048057'
      - '1000112877'
      - '3002806731'
      - '3001698565'
      - '3010315629'
      - '3010598187'
      - '3001451826'
      - '3001236905'
      - '3002807308'
      device_name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
      medical_specialty_description: Unknown
      regulation_number: ''
      device_class: U
  - cfres_id: '41815'
    product_res_number: Z-0001-06
    event_date_initiated: '2005-09-13'
    event_date_posted: '2005-10-04'
    recall_status: Terminated
    event_date_terminated: '2005-12-30'
    res_event_number: '33407'
    product_code: FXY
    k_numbers:
    - K910515
    product_description: Stackhouse FreedomAire Lens/Hood; a sterile disposable protective
      head garment for use with the FreedomAire Surgical Helmet System, providing
      a clear plastic bubble lens and protective head hood to connect to the surgical
      helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems,
      Wheeling, IL 60090
    code_info: 'Part #10450, Catalog # SA-500/US, lot number 16963'
    firm_fei_number: '3011270181'
    recalling_firm: VIASYS Med Systems
    address_1: 100 Chaddick Dr
    city: Wheeling
    state: IL
    postal_code: 60090-6006
    additional_info_contact: 'Ms. Stephanie Wasielewski

      800-323-6305'
    reason_for_recall: The packaging may be compromised such that sterility of the
      hoods cannot be guaranteed.
    root_cause_description: Other
    action: VIASYS telephoned the direct accounts and sent out follow-up faxes on
      9/13/05. The accounts were informed of the potential for compromised packages
      seals and questionable sterility, and were instructed to check their inventory
      for the affected catalog numbers and lots numbers. The accounts were instructed
      to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange
      for the return goods authorization. The dealers were requested to sub-recall
      the affected product from their customers.
    product_quantity: 481 cases
    distribution_pattern: Nationwide and internationally to Japan, Chile and Switzerland
    openfda:
      k_number:
      - K904276
      - K140588
      - K760865
      - K770261
      - K761070
      - K904969
      - K770257
      - K222214
      - K200493
      - K880431
      - K903533
      - K760855
      - K902677
      device_name: Hood, Surgical
      medical_specialty_description: General, Plastic Surgery
      regulation_number: '878.4040'
      device_class: '2'
      registration_number:
      - '1526350'
      - '3008328679'
      - '1054241'
      - '3033536319'
      - '3013557562'
      - '3020163307'
      - '3002806603'
      - '3010432890'
      - '3030733800'
      - '3036773433'
      - '3014213264'
      - '3016678045'
      - '3031572397'
      - '3008837339'
      - '1721686'
      - '2032098'
      - '3014479313'
      - '3002807090'
      - '3012494290'
      - '3017300722'
      - '3012497308'
      - '1043214'
      - '1055236'
      - '3007309299'
      - '3015967359'
      fei_number:
      - '1526350'
      - '1000112968'
      - '3008328679'
      - '3033536319'
      - '3013557562'
      - '3020163307'
      - '3002806603'
      - '3010432890'
      - '3030733800'
      - '3036773433'
      - '3014213264'
      - '3016678045'
      - '3031572397'
      - '3008837339'
      - '1721686'
      - '3014479313'
      - '3012494290'
      - '3017300722'
      - '3003058448'
      - '3012497308'
      - '1043214'
      - '3006003617'
      - '1000112877'
      - '3007309299'
      - '3015967359'
  - cfres_id: '46524'
    product_res_number: Z-0001-2007
    event_date_initiated: '2006-05-31'
    event_date_posted: '2006-10-03'
    recall_status: Terminated
    event_date_terminated: '2011-07-27'
    res_event_number: '35637'
    product_code: JAA
    k_numbers:
    - K024012
    product_description: GE 4 inch Anterior Cervical Post, GE Part Number 1006385
      or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the
      InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
    code_info: ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV
    firm_fei_number: '1720753'
    recalling_firm: GE OEC Medical Systems, Inc
    address_1: 384 Wright Brothers Dr
    city: Salt Lake City
    state: UT
    postal_code: 84116-2862
    additional_info_contact: 801-328-9300
    reason_for_recall: Weld defect- the weld between the post body and the screw was
      not properly formed and can fail, even when minimal force is used.
    root_cause_description: Process control
    action: Consignees were notified by letter on 05/31/2006
    product_quantity: 143 units
    distribution_pattern: Nationwide, including one VA facility in PA. No military
      distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
    openfda:
      k_number:
      - K840134
      - K812775
      - K833230
      - K233945
      - K963617
      - K954590
      - K950971
      - K992603
      - K902583
      - K973067
      - K912380
      - K982345
      - K873985
      - K021021
      - K961207
      - K915592
      - K251650
      - K180589
      - K910384
      - K061028
      - K800639
      - K212890
      - K973073
      - K160301
      - K926434
      - K150306
      - K864584
      - K843972
      - K812217
      - K141541
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      - K900893
      - K810189
      - K932445
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      - K811094
      - K200965
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      - K812963
      - K972442
      - K952456
      - K942674
      - K942019
      - K112054
      - K161019
      - K970947
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      - K893644
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      - K051136
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      - K163210
      - K896331
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      - K151485
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      - K854953
      - K912341
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      - K840621
      - K914446
      - K874901
      - K875157
      - K933100
      - K925251
      - K920720
      - K926122
      - K943532
      - K004037
      - K810716
      - K884578
      - K960266
      - K040870
      - K895730
      - K874905
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      - K842217
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      - K203087
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      - K840191
      - K944973
      - K871127
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      - K953113
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      - K131075
      - K771298
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      - K864749
      - K970608
      - K943447
      - K973744
      - K070390
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      - K121293
      - K081621
      - K020055
      - K872061
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      - K191504
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      - K953950
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      - K923585
      - K080859
      - K022911
      - K770337
      - K890745
      - K890878
      - K924164
      - K930885
      - K232526
      registration_number:
      - '3009973505'
      - '3010398867'
      - '2027062'
      - '9680001'
      - '3011950073'
      - '1052701'
      - '1054713'
      - '3014343100'
      - '3021559833'
      - '2126677'
      - '9611388'
      - '1125622'
      - '3001556265'
      - '3012127758'
      - '3003202425'
      - '1717855'
      - '3005706667'
      - '3009144915'
      - '1225677'
      - '9610903'
      - '3006972752'
      - '9681146'
      - '2020550'
      - '3011158427'
      - '3033525987'
      - '8030112'
      - '3030412764'
      - '1048735'
      - '1723170'
      - '1061158'
      - '1056553'
      - '3015223550'
      - '3008632256'
      - '3011416394'
      - '3009196578'
      - '1038913'
      - '3013099020'
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      - '3003768251'
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      device_name: System, X-Ray, Fluoroscopic, Image-Intensified
      medical_specialty_description: Radiology
      regulation_number: '892.1650'
      device_class: '2'
  - cfres_id: '53825'
    product_res_number: Z-0001-2008
    event_date_initiated: '2007-07-26'
    event_date_posted: '2007-11-03'
    recall_status: Terminated
    event_date_terminated: '2009-08-12'
    res_event_number: '38473'
    product_code: GWQ
    k_numbers:
    - K052066
    product_description: Bio-logic System Corp --Telescoping Camera Pole Assembly
      (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART;
      Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is
      used with the 580-PNCART that is wired for use with a Panasonic Camera.  The
      pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART
      wired for the use with an Ipela Camera.  Both carts are a component of the Ceegraph/Sleepscan
      Netlink with Video.
    code_info: Pole assembly 580-VIDPOL and 585-CYBPSM, used with Models 580-IPCART
      and 580-PNCART - the cart component of the Ceegraph/Sleepscan Netlink with Video.  There
      are no serial numbers on the pole assembly.
    firm_fei_number: '1419887'
    recalling_firm: Bio-Logic Systems Corp
    address_1: 1 Bio Logic Plaza
    city: Mundelein
    state: IL
    postal_code: 60060-3708
    additional_info_contact: 'Customer Support

      800-332-3114'
    reason_for_recall: Bio-logic System Corp Camera Pole may weaken and detach at
      the base of the telescoping camera pole during transport causing pole to break
      at the welded base and fall.
    root_cause_description: Device Design
    action: 'Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers,
      warning them that using the pole to transport the cart may cause the weld at
      the base of the pole to weaken, causing it to break.  As a precaution to ensure
      customer safety, the accounts were instructed to place the enclosed red sticker
      on the pole, below the tightening knob. An Instruction sheet is enclosed . The
      warning label reads: "Caution: Do not use as a handle to move cart.  Always
      lower camera when transporting.  Avoid sudden stops or collisions."   The accounts
      were requested to complete and return an enclosed reply sheet acknowledging
      the receipt of the letter and the placement of the warning labels on the poles.  Any
      questions were directed to Customer Support at 1-800-332-3114.'
    product_quantity: 311 units
    distribution_pattern: Worldwide Distribution -- USA and China, Egypt, Hong Kong,
      Israel, Malaysia and Saudi Arabia
    openfda:
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      registration_number:
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      - '3023272766'
      - '3003208775'
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      - '3002809369'
      - '3001610756'
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      - '3012494290'
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      - '3004674371'
      - '3007962724'
      - '3027532607'
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      - '3007701713'
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      - '3002807720'
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      - '3010157426'
      - '3008881376'
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      - '3038189172'
      - '3020223448'
      - '1000300598'
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      - '6736'
      - '3000126629'
      - '3023707151'
      - '3020018'
      - '3012528160'
      - '3002807739'
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      - '3003757840'
      - '3006125362'
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      - '3003255845'
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      device_name: Full-Montage Standard Electroencephalograph
      medical_specialty_description: Neurology
      regulation_number: '882.1400'
      device_class: '2'
  parser_errors:
  - 'Partial response: 100 of 59102 provider records'
  logical_asset_id: null
related_dataset_ids: []
quality:
  score: 80
  parsing_errors:
  - 'Partial response: 100 of 59102 provider records'
  stale_warning: null
  broken_source_report: null
rss_feed_url: null
odc_version: '0.1'
last_successful_scan_at: null

Revision dbt Source YAML

Open raw YAML

version: 2
sources:
- name: fda_device_recalls
  description: FDA Device Recall Reports Sample discovered from api.fda.gov. Bounded
    source query (limit=100); completeness is not assumed.
  meta:
    opendataodc:
      dataset_id: fda-device-recalls
      revision_id: 20260907135529-a7cd5d0f3305
      detected_at: '2026-09-07T13:55:29+00:00'
      source_url: https://api.fda.gov/device/recall.json?limit=100
  tables:
  - name: recall_json
    description: Source asset recall.json.
    meta:
      opendataodc:
        source_url: https://api.fda.gov/device/recall.json?limit=100
        content_hash: d7351bbcbb39cb42bfae873fb6cccc2cf5d72d115d3624525328258d7ffba040
        row_count: 100
        parser_errors:
        - 'Partial response: 100 of 59102 provider records'
    columns:
    - name: action
    - name: additional_info_contact
    - name: address_1
    - name: address_2
    - name: cfres_id
    - name: city
    - name: code_info
    - name: country
    - name: distribution_pattern
    - name: event_date_created
    - name: event_date_initiated
    - name: event_date_posted
    - name: event_date_terminated
    - name: firm_fei_number
    - name: k_numbers
    - name: openfda
    - name: pma_numbers
    - name: postal_code
    - name: product_code
    - name: product_description
    - name: product_quantity
    - name: product_res_number
    - name: reason_for_recall
    - name: recall_status
    - name: recalling_firm
    - name: res_event_number
    - name: root_cause_description
    - name: state

Sample Rows