The Recall Desk

Hazard

Missing Instructions recalls

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

What the numbers show

Total
30
Critical
0
Severe
1
Most recent
2025-09-03

Of the 30 missing instructions recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) 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 missing instructions 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 30

  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2023·2022-12-14

    Bipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions

    Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2023·2022-12-14

    Carefusion Bipolar Forceps Recalled Due to Incomplete Instructions

    Carefusion recalled 84 units of HARDY-STYLE BAYONET BIPOLAR FORCEPS nationwide and internationally due to incomplete Instructions for Use. The distributed documentation is missing information about power supply interface, cleaning, and maintenance procedures.

    Product
    Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2023·2022-11-09

    EKOS Control Unit 4.0 Recalled for Missing or Incorrect Instructions

    Boston Scientific is recalling 16 EKOS Control Unit 4.0 consoles that were shipped without proper instructions for use or with incorrect instructions, creating risk of improper device operation.

    Product
    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0132-2023·2022-11-02

    Vortex MP Port Titanium Recalled for Missing Printed Instructions

    Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.

    Product
    Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0833-2022·2022-04-06

    CareFusion Endoscopic Equipment Recalled for Missing Instructions for Use

    CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.

    Product
    (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2244-2021·2021-08-25

    Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect

    Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.

    Product
    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2021·2021-02-10

    Allergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions

    Allergan PLC is recalling Refresh Contacts Contact Lens Comfort Drops because the packages are missing the Instruction For Use insert. Consumers should stop using the product and contact the manufacturer.

    Product
    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2567-2018·2018-08-08

    Howmedica Custom Implant System Recalled for Missing Instructions

    Howmedica is recalling five custom implant systems because they lacked updated instructions clarifying the locking mechanism and screw warnings.

    Product
    Custom Made Implant System with Minimum Invasive Grower (MIG) component
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2001-2017·2017-05-10

    Anspach Pneumatic Attachment Recalled for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 9,829 pneumatic attachments because the supplied directions for use did not include a recommended service interval.

    Product
    12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

    Product
    Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0365-2017·2016-11-16

    FDA Recalls Covidien Devon Light Glove Sub-Assembly for Added Instructions

    The FDA is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly to add instructions for use regarding barrier integrity inspection.

    Product
    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Instructions in Manual

    Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because critical safety information was missing from the instruction manual.

    Product
    IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2349-2015·2015-08-12

    Zimmer Surgical Recalls Tourniquet Cuffs with Missing Instructions

    Zimmer Surgical Inc. is recalling 330 units of 30-inch tourniquet cuffs because the instructions for use were missing usage instructions and warnings.

    Product
    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder
    Category
    Medical Device
    Distribution
    45 states
  • LowFDA (Devices)·Z-1610-2015·2015-05-20

    Zimmer Hemovac Mini Evacuator Recalled for Missing Instructions for Use

    Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.

    Product
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0111-2014·2013-11-06

    Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions

    Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.

    Product
    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2013·2013-08-28

    Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions

    Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.

    Product
    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2013·2013-06-05

    Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
    Category
    Medical Device
    Distribution
    Distributed nationwide