The Recall Desk

Hazard

Physical Defect 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
0
Severe
4
Most recent
2023-04-19

Of the 65 physical defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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 physical 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.

1–25 of 65

  • HighFDA (Devices)·Z-1380-2023·2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-1431-2021·2021-04-28

    Bard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects

    C.R. Bard is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters because the catheter tip was cut off and the packaging was not fully sealed.

    Product
    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2021·2021-01-06

    ROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges

    ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.

    Product
    Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1545-2020·2020-09-02

    Hetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints

    Hetero Labs is recalling 43,512 bottles of Losartan Potassium 50 mg tablets due to a complaint of bulging tablets.

    Product
    Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0638-2020·2020-01-15

    Lupin Recalls Blisovi Fe 1.5/30 Tablets Due to Crumbling

    Lupin Pharmaceuticals is recalling Blisovi Fe 1.5/30 tablets because they crumble when removed from the blister pack.

    Product
    Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF p
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0556-2019·2018-12-12

    Pfizer Recalls Thermacare Heatwraps Due to Material Leakage

    Pfizer is recalling specific lots of Thermacare Heatwraps because the wraps may come apart and leak granular material.

    Product
    Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2916-2018·2018-08-29

    Johnson & Johnson Recalls 1-Day ACUVUE MOIST Contact Lenses

    Johnson & Johnson Vision Care is recalling specific lots of 1-Day ACUVUE MOIST contact lenses due to reports of partially formed lenses that appear smaller and stiffer.

    Product
    Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2018·2018-04-11

    C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.

    Product
    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility

    Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2018·2017-11-29

    ICU Medical Recalls IV Sets with Potential Metallic Burrs in Stopcocks

    ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.

    Product
    SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rota
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2803-2017·2017-08-09

    Quidel Recalls InflammaDry Sample Collectors Due to Plastic Spurs

    Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.

    Product
    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0921-2017·2017-06-28

    Lucid Pharma Recalls Venlafaxine Hydrochloride Extended-Release Capsules Due to Melted Capsules

    Lucid Pharma LLC is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, because pharmacists reported bottles containing melted capsules.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2017·2017-04-12

    Genentech Recalls Cotellic Tablets Due to Oversized Tablet Discovery

    Genentech is recalling 748 bottles of Cotellic (cobimetinib) tablets because an oversized tablet was found in a bottle. The affected product was distributed in New Jersey and Illinois.

    Product
    COTELLIC — COTELLIC (COBIMETINIB)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0474-2017·2017-02-22

    Aurobindo Recalls Venlafaxine Hydrochloride Capsules Due to Physical Defects

    Aurobindo Pharma USA Inc is recalling 47,040 bottles of Venlafaxine Hydrochloride extended-release capsules because some contain punctured or clumped capsules.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2017·2017-02-22

    Accord Healthcare Recalls Lisinopril Tablets Due to Missing Break Line

    Accord Healthcare is recalling 12,896 bottles of 5 mg Lisinopril tablets because the tablets are missing a break line. The recall covers the U.S. and Puerto Rico.

    Product
    Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0224-2017·2016-12-28

    Inventia Recalls Duloxetine Capsules Due to Broken Shells

    Inventia Healthcare is recalling Duloxetine Delayed-Release Capsules 30 mg because capsule shells were found opening inside the bottles.

    Product
    Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2016·2016-02-10

    Pfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells

    Pfizer is recalling specific lots of Lyrica (pregabalin) 50 mg capsules due to the potential presence of deformed or damaged capsules.

    Product
    LYRICA — LYRICA (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide