The Recall Desk

Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,434
Critical
7
Severe
107
Most recent
2026-09-02

Of the 1,434 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 107 (7%) 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.

1–25 of 1434

  • HighFDA (Drugs)·N/A·2026-09-02

    Beak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination

    Beak & Skiff Sanitizer Alcohol Antiseptic 80% is being recalled because FDA analysis found acetaldehyde above specification limits in the product. The recall affects bottles distributed in New York and through online sales.

    Product
    Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2885-2026·2026-08-12

    U2 Total Knee System Femoral Valgus Adaptor Recall

    United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2884-2026·2026-08-12

    USTAR II Knee System Hinge Box Trial Recall

    United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.

    Product
    Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2883-2026·2026-08-12

    Knee Prosthesis Trial Recall for Manufacturing Defect

    United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.

    Product
    Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2026·2026-08-12

    United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System

    United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2026·2026-07-29

    Penumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk

    Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.

    Product
    Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2681-2026·2026-07-22

    ABIOMED Impella RP Flex heart pump introducer sheath leakage risk

    Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2679-2026·2026-07-22

    Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk

    Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.

    Product
    Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2680-2026·2026-07-22

    Abiomed Impella Introducer Kit recalled for potential fluid leakage

    Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.

    Product
    Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2678-2026·2026-07-22

    Abiomed Impella Introducer Kit Recalled Due to Potential Leakage

    Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.

    Product
    Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2685-2026·2026-07-22

    Abiomed Impella CP Introducer Kit heart pump accessory recall

    Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2693-2026·2026-07-22

    ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk

    Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.

    Product
    ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2026·2026-07-22

    ABIOMED Insertion Kit heart pump accessories introducer sheath leakage

    Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2691-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2677-2026·2026-07-15

    Aquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness

    ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.

    Product
    Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2026·2026-07-08

    Medline Convenience Kits Block Tray recalled due to quality defects

    Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.

    Product
    Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2026·2026-07-08

    Medline Suturing Set with Lidocaine Ampules Recalled

    Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2663-2026·2026-07-08

    PowerMidline Catheter 4 Fr Dual-Lumen due to deficient manufacturing

    Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2660-2026·2026-07-08

    Power-Trialysis Dialysis Catheters Recalled Due to Manufacturing Defects

    Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.

    Product
    5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2656-2026·2026-07-08

    Poly Midline Catheters recalled due to manufacturing defects

    Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline cathet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2666-2026·2026-07-08

    PowerPICC Catheters recalled for deficient manufacturing practices

    Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.

    Product
    1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2658-2026·2026-07-08

    PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall

    Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.

    Product
    CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2665-2026·2026-07-08

    Groshong NXT ClearVue Catheter Recalled Due to Manufacturing Deficiency

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.

    Product
    7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide