The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing 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.

51–75 of 1441

  • HighFDA (Devices)·Z-1860-2026·2026-04-29

    Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2026·2026-04-29

    Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent the guidewire from passing through the catheter hub. The defect affects 1,030 units distributed worldwide.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2026·2026-04-29

    Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect

    Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2026·2026-04-29

    AccuVu Angiographic Catheter recall due to manufacturing defect

    Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2026·2026-04-29

    Arrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect

    Arrow International is recalling 115 units of its percutaneous sheath introducer with 7.5–8 Fr catheter because the liquid adhesive was incorrectly manufactured by a supplier. The product is used for venous access and central circulation catheterization.

    Product
    PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2026·2026-04-29

    Flamingo Funnel Medium surgical device recall due to sterilization incompatibility

    SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.

    Product
    Flamingo Funnel Medium, Model Number SQ20012-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1914-2026·2026-04-29

    Arrow Pressure Injectable Central Venous Catheters Recalled

    Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2026·2026-04-29

    Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive

    Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.

    Product
    ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2026·2026-04-29

    Flamingo Funnel Small surgical device recalled for sterilization defect

    SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.

    Product
    Flamingo Funnel Small, Model Number SQ20012-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2026·2026-04-29

    Arrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive

    Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.

    Product
    Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2026·2026-04-29

    Flamingo Funnel Large surgical smoke evacuation device recall

    SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

    Product
    Flamingo Funnel Large, Model Number SQ20012-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V266000·2026-04-24

    Audi Q5 front seat belts may fail to restrain occupants

    Audi is recalling certain 2025 Q5, Q5 Sportback, SQ5 and SQ5 Sportback vehicles because the driver and front passenger seat belts may have been manufactured incorrectly.

    Product
    AUDI — AUDI Q5, Q5 SPORTBACK, SQ5, SQ5 SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2026·2026-04-22

    Omnipod 5 insulin pods from 49 lots have torn internal cannulas

    Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.

    Product
    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2026·2026-04-22

    Elegance anterior cervical plates recalled over burrs on finished product

    Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.

    Product
    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423653 may leak

    ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423653, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423643 may leak

    ConvaTec is recalling two lots of the EsteemBody Drainable Pouch, REF 423643, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423657 may leak

    ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423657, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2026·2026-03-18

    Exactech Ergo modular impactor handle may be missing its cross-pin

    Exactech is recalling the Equinoxe Ergo Modular Impactor Handle, model 321-09-05, because the impactor handle may be missing a cross-pin.

    Product
    Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1510-2026·2026-03-18

    Exactech Equinoxe core instrument kits may have handles missing cross-pins

    Exactech is recalling the Equinoxe Core Instrument Kit, model KIT-311X, because the impactor handle may be missing a cross-pin.

    Product
    Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1490-2026·2026-03-11

    Esaote endocavity ultrasound probe recalled because liquid may leak in

    Esaote is recalling five Endocavity ultrasonic probes, model E 3-12, because a potential weakness in the probe body may allow liquid to leak from the casing near the cable.

    Product
    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled Over Sterility Concerns

    Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2026·2026-03-04

    Vista Gonio Eye Lubricant Recalled Due to Sterility Concerns

    Vista Gonio Eye Lubricant eye drops are being recalled because they may not be sterile. The product was not manufactured according to proper sterile drug-making standards.

    Product
    VISTA GONIO EYE LUBRICANT — VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2026·2026-01-28

    Long distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2026·2026-01-28

    Distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
    Category
    Medical Device
    Distribution
    Distributed nationwide