The Recall Desk

Hazard

Incorrect Instructions recalls

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

What the numbers show

Total
25
Critical
0
Severe
0
Most recent
2025-12-03

Of the 25 incorrect 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 0 (0%) 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 incorrect 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 25

  • HighFDA (Devices)·Z-0722-2026·2025-12-03

    Hot and cold wraps recalled over microwave instructions causing burns

    DJO is recalling 1,594 Cold Form Wraps because the instructions tell users to microwave the wrap for three minutes, which may cause leaks or second degree burns.

    Product
    Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Sample preparation systems recalled over incorrect dead volumes in instructions

    Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.

    Product
    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2024·2024-04-24

    Neria Soft Infusion Sets recalled due to incorrect instruction manual

    Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.

    Product
    Neria Soft Infusion Set, Product Code 507302, intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0837-2024·2024-02-07

    FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy

    Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.

    Product
    Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V048000·2023-02-02

    Incorrect defroster instructions in Nissan LEAF owner's manuals increase crash risk

    Nissan is recalling 2018-2023 LEAF vehicles because the Owner's Manual has incorrect defroster operation instructions, which may reduce visibility and increase crash risk. Nissan will mail updated instructions at no charge.

    Product
    NISSAN — NISSAN LEAF
    Category
    Vehicle
    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
  • ModerateFDA (Devices)·Z-1741-2022·2022-09-21

    PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions

    PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.

    Product
    PTS Panels CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0452-2022·2022-01-12

    Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life

    Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.

    Product
    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2022·2021-10-13

    Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions

    Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.

    Product
    Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2520-2021·2021-09-29

    Decompression Needle Recall Due to Incorrect Instructions for Use

    North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.

    Product
    10 ga ARS Decompression Needle, Part Number ZZ-0298
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1770-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Implantable Ports

    Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1767-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters

    Bard Peripheral Vascular Inc is recalling 4,044 POWERPORT ClearVUE catheters because the Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0187-2018·2017-12-20

    Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors

    Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V433000·2017-07-07

    2017 Jeep Compass Recall for Incorrect Jump Start Instructions

    Chrysler is recalling 2017 Jeep Compass vehicles because the User's Guide contains reversed battery terminal polarity for jump starting, which may increase the risk of injury.

    Product
    JEEP — JEEP COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2016·2016-08-17

    Nobel Biocare Recalls Guided Surgery Kit Instructions for Incorrect Drill Protocol

    Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.

    Product
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2012·2012-08-08

    Baxter Recalls Peritoneal Dialysis Solution Due to Incorrect Inspection Instructions

    Baxter Healthcare is recalling Extraneal and DIANEAL Low Calcium peritoneal dialysis solutions because a technical service representative provided incorrect instructions for inspecting solution bags.

    Product
    Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2012·2012-08-01

    Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (49042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2012·2012-08-01

    Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2012·2012-08-01

    Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions

    Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all ot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2012·2012-08-01

    Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other
    Category
    Medical Device
    Distribution
    Distributed nationwide