PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 133 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.70% of the 100,165 total recalls we track from 1995 through the present, and averages roughly 21.1 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 155 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2018.

On this page of 50 records, severity classification shows 3 critical, 44 moderate, and 3 lower-severity recalls. The page references 19 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (29), FDA Drug (21), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2018 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Feb 28, 2018

Esmolol HCl in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, pac…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 5…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Lidocaine HCl in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, pa…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Methadone HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by Ameri…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Midazolam HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Nicardipine HCl in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, …

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) …

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Ropivacaine HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

FDA Drug Moderate Feb 28, 2018

Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133…

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Feb 28, 2018

Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by Am…

American Pharmaceutical Ingredients LLC

FDA Devices Moderate Feb 28, 2018

Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a si…

Medtronic Perfusion Systems

FDA Devices Moderate Feb 28, 2018

Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-…

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holder…

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 28, 2018

ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK…

Cosman Medical, LLC

FDA Devices Low Feb 28, 2018

Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada…

LivaNova USA

FDA Devices Moderate Feb 28, 2018

Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilizat…

Innovasis, Inc

FDA Devices Moderate Feb 28, 2018

Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

Allen Medical Systems

FDA Devices Moderate Feb 28, 2018

3-Way Standardbore Stopcock. Product Code: AMS-100.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visu…

Pentax of America Inc

FDA Devices Moderate Feb 28, 2018

ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142…

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

Hologic, Inc.

FDA Devices Moderate Feb 28, 2018

19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 28, 2018

Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty

Zimmer Biomet, Inc.

FDA Devices Low Feb 28, 2018

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Ivoclar Vivadent, Inc.

FDA Devices Moderate Feb 28, 2018

Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and sid…

Ethicon Endo-Surgery Inc

FDA Devices Moderate Feb 28, 2018

CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Ever…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument hold…

Zimmer Biomet, Inc.

FDA Devices Low Feb 28, 2018

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Ivoclar Vivadent, Inc.

FDA Devices Moderate Feb 28, 2018

Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Exp…

Boston Scientific Corporation

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external de…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 28, 2018

GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surg…

Covidien LLC

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA — consumer product and vehicle recall feeds for 2018