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
2026-09-09

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.

1026–1050 of 1434

  • HighFDA (Devices)·Z-0664-2020·2019-12-18

    Abbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error

    Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.

    Product
    Radiofrequency Grounding Pad, REF RF-DGP-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2020·2019-12-18

    Medtronic Passive Biopsy Needle Kit Recall for Depth Stop Issue

    Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.

    Product
    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
    Category
    Medical Device
    Distribution
    49 states
  • LowFDA (Devices)·Z-0590-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Marker Band Fit Issues

    Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0580-2020·2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0579-2020·2019-12-04

    Boston Scientific Recalls NC Emerge Monorail PTCA Catheters for Coating Defect

    Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.

    Product
    NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H74939
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0578-2020·2019-12-04

    Boston Scientific Recalls Guidezilla II Catheters Due to Missing Coating

    Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.

    Product
    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2020·2019-11-20

    TriMed Wrist Hook Impactors Recalled for Rust Risk

    TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.

    Product
    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2020·2019-11-20

    Orthofix Recalls Elbow Sterile Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Elbow Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0366-2020·2019-11-20

    TriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification

    TriMed Inc. is recalling 583 Olecranon Hook Plates because angled holes may have been modified from specifications without full qualification.

    Product
    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2020·2019-10-16

    K2M Recalls Yukon Polyaxial Screws Due to Manufacturing Error

    K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.

    Product
    YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Cat
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0045-2020·2019-10-16

    Helena Laboratories Recalls SPIFE ImmunoFix-6 Kits Due to Missing Control Wells

    Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.

    Product
    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2447-2019·2019-09-11

    Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect

    Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.

    Product
    Flexible Intubation Fiberscope, Model # 11301AB1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2436-2019·2019-09-11

    Coltene Recalls Diatech Diamond Dental Burs Due to Length Variations

    Coltene is recalling a specific lot of Diatech diamond dental burs because the instruments in the batch vary in length despite having the same shape and grit.

    Product
    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1831-2019·2019-08-28

    Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops

    Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to manufacturing quality control concerns.

    Product
    Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medt
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2019·2019-08-21

    Luminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects

    Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.

    Product
    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2285-2019·2019-08-21

    Luminex ARIES GBS Assay Recalled for Partially Sealed Side Cassettes

    Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.

    Product
    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2287-2019·2019-08-21

    Luminex Recalls ARIES C. difficile Assay Due to Seal Defects

    Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.

    Product
    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Drugs)·D-1739-2019·2019-08-21

    US Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues

    US Pharmaceuticals is recalling Kool Comfort Cooling Pain Relief because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee La
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1734-2019·2019-08-21

    US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues

    US Pharmaceuticals is recalling 651 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    MAXIMUM STRENGTH HYDROCORTISONE CREAM — MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1740-2019·2019-08-21

    US Pharmaceuticals Recalls Wonder Freeze Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling Wonder Freeze Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
    Category
    Drug
    Distribution
    Distributed nationwide