PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 122 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 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 17 distinct recalling firms operating in 2 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (49), CPSC (1), 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 Devices Moderate Mar 21, 2018

NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or c…

Arrow International Inc

FDA Devices Low Mar 21, 2018

T/Pump temperature therapy pump, Models TP700 and TP700C

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Mar 21, 2018

ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Fixed Core Bentson

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the c…

Alden Optical

FDA Devices Moderate Mar 21, 2018

LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FE…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Feature…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the c…

Alden Optical

FDA Devices Moderate Mar 21, 2018

NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to o…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-nata…

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate Mar 21, 2018

Liquid Cardiac Control CQ5053

Randox Laboratories, Limited

FDA Devices Moderate Mar 21, 2018

CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FE…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with…

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Mar 21, 2018

TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligame…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correct…

Alden Optical

FDA Devices Moderate Mar 21, 2018

VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access f…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

TFE Coated Curved Newton LLT

Cook Inc.

FDA Devices Moderate Mar 21, 2018

PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK PRC F…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INT…

Smiths Medical ASD Inc.

FDA Devices Moderate Mar 21, 2018

LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LP…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535

Howmedica Osteonics Corp.

FDA Devices Moderate Mar 21, 2018

JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patien…

Medimop Medical Projects Ltd.

FDA Devices Moderate Mar 21, 2018

Rosen Curved Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the corre…

Alden Optical

FDA Devices Moderate Mar 21, 2018

IMRIS ORT100 Table, Part Number 110470-000

Deerfield Imaging, Inc.

FDA Devices Moderate Mar 21, 2018

CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-F…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutriti…

Becton Dickinson & Co.

FDA Devices Moderate Mar 21, 2018

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumor…

Ion Beam Applications S.A.

FDA Devices Low Mar 21, 2018

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Randox Laboratories

FDA Devices Moderate Mar 21, 2018

Newton Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the corre…

Alden Optical

FDA Devices Moderate Mar 21, 2018

AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access …

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical dev…

Ion Beam Applications S.A.

FDA Devices Moderate Mar 21, 2018

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemen…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labe…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Mar 21, 2018

ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the …

Alden Optical

FDA Devices Moderate Mar 21, 2018

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC i…

Arrow International Inc

CPSC Moderate Mar 21, 2018

Kidde Recalls Dual Sensor Smoke Alarms Due to Risk of Failure to Alert Consumers to a Fire

Fyrnetics Limited, of Hong Kong

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