The Recall Desk

Hazard

Specification Failure recalls

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

What the numbers show

Total
108
Critical
2
Severe
7
Most recent
2026-07-08

Of the 108 specification failure recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (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 specification failure 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.

76–100 of 108

  • HighFDA (Devices)·Z-1860-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheters for Antimicrobial Defects

    The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2015·2015-07-08

    Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1851-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2015·2015-07-08

    FDA Recalls Palindrome HSI Chronic Catheter Kits for Antimicrobial Spec Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z1856-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2015·2015-04-15

    CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date

    CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.

    Product
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2014·2014-10-01

    Vidacare EZ-IO Needle Set Recalled for Specification Failures

    Vidacare Corporation is voluntarily recalling 172 units of EZ-IO 45mm Needle Sets because they do not meet specifications.

    Product
    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2014·2014-06-11

    CryoLife Recalls BioGlue Surgical Adhesive Due to Albumin Component Failure

    CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.

    Product
    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-076-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.088 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.088 mg. tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-078-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.112 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-074-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab tablets because they failed to meet in-process specification requirements.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-082-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.7 million Thyro-Tab tablets because they do not meet in-process specification requirements and involve cGMP deviations.

    Product
    Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-083-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-079-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements due to cGMP deviations.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-084-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.300 mg Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,902,957 Thyro-Tab 0.300 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-081-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-077-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets because they failed to meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-080-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.125 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,924,174 tablets of Thyro-Tab 0.125 mg. (Lot #HB27811) because the product does not meet in-process specification requirements.

    Product
    Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-075-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific bottles of Levothroid tablets because they failed to meet in-process specification requirements during manufacturing.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide