May 2024 recalls

616 recalls were announced in May 2024.

What the numbers show

Critical: 13
Severe: 129
High: 400
Moderate: 72
Low: 2

Of the 616 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

Which agencies issued them

601–616 of 616

HighFDA (Devices)·Z-1617-2024·2024-05-01
Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage
The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.
Product
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1637-2024·2024-05-01
Medical diagnostic test kits recalled due to misaligned results window
Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1631-2024·2024-05-01
Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1618-2024·2024-05-01
Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure
EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.
Product
20" Lead Wires, Replacement Part Number: 1067724-2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2024·2024-05-01
Water bottles used in dental treatment devices recalled for disassembly risk
Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure during treatment or storage. No injuries have been reported.
Product
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2024·2024-05-01
Hip Implant Acetabular Shell Recalled for Manufacturing Defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.
Product
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1177-2024·2024-05-01
Amy's Kitchen Enchilada Verde Whole Meal Recalled for Listeria Contamination
Amy's Kitchen Enchilada Verde frozen meals are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed to 21 U.S. states.
Product
Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
Category
Food
Distribution
21 states
ModerateFDA (Devices)·Z-1689-2024·2024-05-01
Baxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution
Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.
Product
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1203-2024·2024-05-01
PepsiCo Root Beer Mislabeled; Regular Mug Sold as Zero Sugar
PepsiCo is recalling 2,801 cases of 12-pack Mug root beer that were mislabeled as Mug Zero Sugar but contain regular Mug. The error affects product distributed across six states.
Product
12 oz Aluminum cans of root beer packaged 12 cans per carton. 2/12pks per case
Category
Food
Distribution
6 states
ModerateFDA (Drugs)·D-0467-2024·2024-05-01
Prescription antipsychotic tablets Abilify recalled for cross-contamination with other products
Certain lots of Abilify (aripiprazole) 10 mg tablets are being recalled due to cross-contamination with other products. Affected products were distributed nationwide.
Product
ABILIFY — ABILIFY (ARIPIPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0468-2024·2024-05-01
Prescription Drug Recall: ABILIFY Tablets Due to Cross Contamination
ABILIFY (aripiprazole) 15 mg tablets from lot AMS00223A are being recalled due to cross contamination with other products. The recall affects packages distributed nationwide.
Product
ABILIFY — ABILIFY (ARIPIPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0466-2024·2024-05-01
Prescription medication Abilify recalled for cross contamination with other products
Otsuka America Pharmaceutical is recalling certain lots of Abilify (aripiprazole) 5 mg tablets distributed nationwide due to cross contamination with other products. This is classified as a Class III recall.
Product
ABILIFY — ABILIFY (ARIPIPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0461-2024·2024-05-01
Eyewash Solution Recalled for Manufacturing Compliance Deviations
Honeywell Inc. is recalling FENDALL 2000 PURE FLOW eyewash solution due to Current Good Manufacturing Practice deviations. The recall affects 10,605 cartridges distributed nationwide in the USA and Canada with expiration dates through June 2025.
Product
FENDALL 2000 PURE FLOW — FENDALL 2000 PURE FLOW (PURIFIED WATER)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0465-2024·2024-05-01
FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect
Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.
Product
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0469-2024·2024-05-01
Prescription drug Abilify 30mg tablets recalled for cross-product contamination
Abilify (aripiprazole) 30mg tablets are being recalled due to cross-contamination with other products. The affected lots were distributed nationwide in the United States.
Product
ABILIFY — ABILIFY (ARIPIPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1633-2024·2024-05-01
3M Durapore Surgical Tape incorrectly labeled with extended shelf life
Select lots of 3M Durapore Surgical Tape (Catalog Number 1538-118) were labeled with a 5-year shelf life when the actual shelf life is 3 years. The recall affects over 3.5 million rolls distributed worldwide.
Product
3M Durapore Surgical Tape, Catalog Number 1538-118
Category
Medical Device
Distribution
Distributed nationwide

Looking for a different month? Back to 2024.