The Recall Desk

Hazard

Manufacturing Validation recalls

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

What the numbers show

Total
22
Critical
0
Severe
0
Most recent
2023-08-09

Of the 22 manufacturing validation 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 manufacturing validation 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.

1–22 of 22

  • HighFDA (Drugs)·D-0988-2023·2023-08-09

    Norepinephrine IV bags recalled for sterility validation deficiency

    Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.

    Product
    norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2022·2022-06-08

    Busse Hospital Disposables Recalls Convenience Kits with Swab Products

    Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.

    Product
    Pellet Insertion Tray Catalog Number: B1654
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue

    Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2022·2022-06-08

    FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.

    Product
    CVC Dressing Change Kit Catalog Number: 2491R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2022·2022-06-08

    Universal Nerve Block Tray swab products recalled for manufacturing test validation concerns

    Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.

    Product
    Universal Nerve Block Tray Catalog Number: 9779
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1191-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.

    Product
    SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2022·2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.

    Product
    Epidural Tray Catalog 1307
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2022·2022-06-08

    Procedure Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.

    Product
    Procedure Tray Catalog 1065
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1194-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Inadequate Manufacturing Test Validation

    Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2022·2022-06-08

    Lumbar Tray with Swab Products Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.

    Product
    Lumbar Tray Catalog 1091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1184-2022·2022-06-08

    Pellet Insertion Tray Recall for Uncertain Manufacturing Test Validation

    Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2022·2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2022·2022-06-08

    Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation

    Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Cervical Tray Catalog 1089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1006-2022·2022-05-04

    IV Start Kit convenience kits recalled for manufacturing validation defect

    ROi CPS LLC recalled 950 IV Start Kit convenience kits due to potential inadequacy in manufacturing test method validation. No injuries reported.

    Product
    Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue

    ROi CPS LLC is recalling 290 convenience kits containing IV Start Kits due to potential inadequacy in the validation of test methods used during manufacturing. Distribution was in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2022·2022-04-13

    DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods

    DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.

    Product
    DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0570-2022·2022-03-02

    Prevantics Maxi Swabstick Recall Due to Manufacturing Validation Issues

    Professional Disposables International is recalling Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) due to unvalidated test methods used during manufacturing. The company has not reported any illnesses or injuries.

    Product
    PREVANTICS MAXI SWABSTICK — PREVANTICS MAXI SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide