The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) 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 defect 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.

276–300 of 450

  • HighFDA (Devices)·Z-2469-2019·2019-09-11

    B. Braun Medical Recalls Epidural Tuohy Needle Filters Due to Membrane Damage

    B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.

    Product
    CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2473-2019·2019-09-11

    B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage

    B. Braun Medical is recalling 200 units of Accu-Bloc Perifix Kits because damaged filter membranes may prevent the device from achieving required filter capacity.

    Product
    CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2378-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2386-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2382-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK hemodialysis catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2372-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2381-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling 2 units of Equistream XK hemodialysis catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2374-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defect

    Bard Peripheral Vascular Inc is recalling 13 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2375-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defects

    Bard Peripheral Vascular Inc is recalling 39 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2370-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling 40 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2220-2019·2019-08-14

    ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets

    ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.

    Product
    Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2221-2019·2019-08-14

    ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets

    ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.

    Product
    Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1770-2019·2019-07-17

    Becton Dickinson Recalls Alaris Pump Infusion Sets Due to Occlusion Defect

    Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.

    Product
    Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1908-2019·2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1376-2019·2019-06-05

    Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement

    Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.

    Product
    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Devices Due to Foil Separation

    Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2019·2019-06-05

    Terumo SOLOPATH Re-Collapsible Access System Recalled for Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.

    Product
    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2019·2019-06-05

    Terumo Recalls SoloPath Balloon Expandable TransFemoral Systems Due to Tip Dislodgement Risk

    Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.

    Product
    SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Partial Foil Separation

    Teleflex Medical is recalling 2,325 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1267-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling Curved Intraluminal Staplers, Model CDH21A, because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 1000 Medical Devices

    Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 1000 sterile, disposable, one-patient use devices due to a Class II safety concern.

    Product
    Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2019·2019-04-17

    Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks

    Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.

    Product
    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2019·2019-02-06

    Medtronic Recalls Reservoir Y Adapters Due to Tearing and Cracking

    Medtronic is recalling 1,100 Reservoir Y Adapters because the Y-connectors may tear or crack, potentially causing blood loss and circuit breaches during autotransfusion.

    Product
    RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2019·2018-11-14

    Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks

    Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.

    Product
    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2019·2018-11-14

    Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets

    Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.

    Product
    PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.
    Category
    Medical Device
    Distribution
    Distributed nationwide