PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 121 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 16 distinct recalling firms operating in 1 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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

Left Atrial Catheter Set

Cook Inc.

FDA Devices Moderate Mar 21, 2018

LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use…

Laerdal Medical Corporation

FDA Devices Moderate Mar 21, 2018

VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an …

Medtronic Minimally Invasive Therapies Group

FDA Devices Moderate Mar 21, 2018

VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Bentson Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

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

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MI…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes…

Hyphen BioMed

FDA Devices Moderate Mar 21, 2018

IMRIS T2X Table, Part Number 109682-600

Deerfield Imaging, Inc.

FDA Devices Moderate Mar 21, 2018

Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the…

Alden Optical

FDA Devices Moderate Mar 21, 2018

ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA…

Hyphen BioMed

FDA Devices Moderate Mar 21, 2018

fastener, fixation, nondegradable, soft tissue

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Amplatz Extra Stiff Whisker Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Central Venous Catheter Tray

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Fixed Core Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to …

Baxter Healthcare Corporation

FDA Devices Moderate Mar 21, 2018

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

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

Bentson Plus Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

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

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

ReWalk Personal 6.0. Catalog number: 50-20-0004.

Argo Medical Technologies Ltd

FDA Devices Moderate Mar 21, 2018

ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous acces…

Arrow International Inc

FDA Devices Moderate Mar 21, 2018

LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS O…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

3M Company - Health Care Business

FDA Devices Moderate Mar 21, 2018

Disposable Reuter Tip Deflecting Wire Guide

Cook Inc.

FDA Devices Moderate Mar 21, 2018

CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannul…

Zimmer Biomet, Inc.

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 Low Mar 21, 2018

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

Randox Laboratories

FDA Devices Moderate Mar 21, 2018

VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 21, 2018

NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requ…

Alden Optical

FDA Devices Moderate Mar 21, 2018

RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Contro…

Stanbio Laboratory, LP

FDA Devices Moderate Mar 21, 2018

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737

Howmedica Osteonics Corp.

FDA Devices Moderate Mar 21, 2018

INFINITY DUAL HEMO MCable Pod

Draegar Medical Systems, Inc.

FDA Devices Moderate Mar 21, 2018

Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correct…

Alden Optical

FDA Devices Moderate Mar 21, 2018

Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correct…

Alden Optical

FDA Devices Moderate Mar 21, 2018

TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during ante…

Zimmer Biomet, Inc.

FDA Devices Low Mar 21, 2018

HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the op…

Philips Electronics North America Corporation

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