The Recall Desk

Hazard

Manufacturing Error recalls

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

What the numbers show

Total
65
Critical
1
Severe
12
Most recent
2026-06-24

Of the 65 manufacturing error recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (18%) 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 error 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 65

  • HighFDA (Devices)·Z-2456-2026·2026-06-24

    TRIGEN proximal humeral nails are missing their distal holes

    TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.

    Product
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1633-2026·2026-04-01

    Straumann angled custom abutments made from wrong bar material

    Straumann is recalling Custom Abutment AS Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2026·2026-04-01

    Straumann custom abutments made from wrong bar material after mix-up

    Straumann is recalling Custom Abutment Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2026·2026-03-04

    Medtronic tissue stabilizer recalled after tubing was assembled in reverse

    Medtronic is recalling one lot of the Octopus Nuvo Tissue Stabilizer after identifying an assembly issue in which the short and long tubes were attached to the wrong ends of the canister.

    Product
    Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2025·2025-08-13

    DASH COVID and flu tests may give a false negative result

    DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.

    Product
    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2230-2025·2025-08-06

    RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes

    A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.

    Product
    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight scleral lenses made with sagittal height or haptic errors

    BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2025·2025-07-23

    NIO-A intraosseous device stabilizer may not release properly after insertion

    The NIO-A NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 7,056 US units affected.

    Product
    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2025·2025-07-23

    NIO+ intraosseous device stabilizer may not release properly after insertion

    The NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 516 US units affected.

    Product
    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2025·2025-07-16

    Preat Astra dental analogs have rotational feature 180 degrees off

    Preat Astra EV-compatible 4.2 mm Digital Analogs are being recalled because a manufacturing error left the digital analog rotational feature 180 degrees off. 44 units are affected.

    Product
    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2022·2022-03-23

    Wright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging

    Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.

    Product
    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1562-2021·2021-05-19

    Musculoskeletal Transplant Foundation Recalls AFT Straight Tubes Due to Filling Error

    Musculoskeletal Transplant Foundation is recalling AFT Straight Tubes that were filled only halfway instead of three-quarters, which may cause surgery delays.

    Product
    AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0323-2021·2021-04-14

    Washington Homeopathic Products Recalls LCL-2-0191 Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling LCL-2-0191 because it was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0426-2021·2020-11-18

    Epitope Diagnostics Recalls COVID-19 IgG ELISA Kits Due to Water Use

    Epitope Diagnostics is recalling 2,886 units of its Novel Coronavirus COVID-19 IgG ELISA Kit because deionized water was used instead of distilled water during manufacturing.

    Product
    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering ca
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-3000-2020·2020-09-30

    ArthroCare Recalls SmartStitch Connectors Due to Manufacturing Error

    ArthroCare Corporation is voluntarily recalling 15,559 units of Smith&Nephew SmartStitch PerfectPasser Connectors because a manufacturing error may cause the upper jaw to detach during use.

    Product
    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Drugs)·D-1389-2020·2020-07-22

    Keryx Recalls Auryxia Tablets Due to Manufacturing Process Deviations

    Keryx Biopharmaceuticals is recalling 59,820 bottles of Auryxia (ferric citrate) tablets because they were not manufactured in conformance with the FDA-approved process.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 7133
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2331-2020·2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1915-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.

    Product
    REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1728-2020·2020-04-29

    Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error

    Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.

    Product
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2020·2020-04-01

    BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1579-2020·2020-04-01

    Bard PowerFlow Apheresis IV Port Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 296 PowerFlow Implatable Apheresis IV Ports because they may contain an incorrect tunneler tip, potentially prolonging surgical operations.

    Product
    PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2020·2020-04-01

    Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
    Category
    Medical Device
    Distribution
    Distributed nationwide