PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 120 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 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 2 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (43), FDA Drug (7), 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 Mar 21, 2018

methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL …

Sagent Pharmaceuticals Inc

FDA Drug Moderate Mar 21, 2018

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Heter…

Hetero Labs Limited Unit V

FDA Drug Moderate Mar 21, 2018

methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL…

Sagent Pharmaceuticals Inc

FDA Drug Moderate Mar 21, 2018

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

American Pharmaceutical Ingredients LLC

FDA Drug Moderate Mar 21, 2018

methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL…

Sagent Pharmaceuticals Inc

FDA Drug Critical Mar 21, 2018

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medici…

Pfizer Inc.

FDA Drug Moderate Mar 21, 2018

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharma…

American Pharmaceutical Ingredients LLC

FDA Devices Moderate Mar 21, 2018

PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO …

Smiths Medical ASD Inc.

FDA Devices Moderate Mar 21, 2018

NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons re…

Alden Optical

FDA Devices Moderate Mar 21, 2018

CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and dis…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Coons Interventional Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Movable Core Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

Diagnostica Stago, Inc.

FDA Devices Moderate Mar 21, 2018

BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determina…

Becton Dickinson & Company

FDA Devices Moderate Mar 21, 2018

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

Medtronic Minimally Invasive Therapies Group

FDA Devices Moderate Mar 21, 2018

ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) centr…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

Diagnostica Stago, Inc.

FDA Devices Moderate Mar 21, 2018

CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR O…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Amplatz Extra Stiff Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).

Diagnostica Stago, Inc.

FDA Devices Moderate Mar 21, 2018

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

3M Company - Health Care Business

FDA Devices Moderate Mar 21, 2018

Amplatz Ultra Stiff Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Bentson Cerebral Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ve…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

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

FDA Devices Moderate Mar 21, 2018

Femoral Artery Pressure Monitoring Set

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Reuter Tip Deflecting Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ C…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

Diagnostica Stago, Inc.

FDA Devices Moderate Mar 21, 2018

OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01…

ZOLL Medical Corporation

FDA Devices Moderate Mar 21, 2018

ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical acceler…

Brainlab AG

FDA Devices Moderate Mar 21, 2018

CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HA…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicate…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Amplatz Stiff Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is …

Ion Beam Applications S.A.

FDA Devices Moderate Mar 21, 2018

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine …

Stryker Corporation

FDA Devices Moderate Mar 21, 2018

Double Flexible Tipped Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS…

ORTHO SOLUTIONS, LTD.

FDA Devices Moderate Mar 21, 2018

36MM COCR MODULAR HD -6MM

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Zimmer Biomet, Inc.

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