PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 137 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, 49 moderate, and 1 lower-severity recalls. The page references 30 distinct recalling firms operating in 3 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (48), CPSC (2), 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 Feb 21, 2018

Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small v…

Arrow International Inc

FDA Devices Moderate Feb 21, 2018

Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage…

Cook Inc.

FDA Devices Moderate Feb 21, 2018

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

OrthoPediatrics Corp

FDA Devices Moderate Feb 21, 2018

CORAIL HIGH OFFSET STEM Collarless SIZE 14

DePuy Orthopaedics, Inc.

FDA Devices Moderate Feb 21, 2018

Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional…

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Arrow International Inc

FDA Devices Moderate Feb 21, 2018

AVID Medical QA Pack AV10654-10

Avid Medical, Inc.

FDA Devices Moderate Feb 21, 2018

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PP…

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 21, 2018

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 0036570…

Roche Diabetes Care, Inc.

FDA Devices Moderate Feb 21, 2018

3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is inten…

3M Company - Health Care Business

FDA Devices Moderate Feb 21, 2018

Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run …

Beckman Coulter Inc.

FDA Devices Moderate Feb 21, 2018

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Feb 21, 2018

Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Ster…

Kalila Medical

FDA Devices Moderate Feb 21, 2018

Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

Gibson Laboratories LLC

FDA Devices Moderate Feb 21, 2018

Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, e…

Hologic, Inc

FDA Devices Moderate Feb 21, 2018

PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to…

3M Company - Health Care Business

FDA Devices Moderate Feb 21, 2018

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to…

Zimmer Surgical Inc

FDA Devices Moderate Feb 21, 2018

Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tom…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 21, 2018

Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional ane…

B. Braun Medical, Inc.

FDA Devices Low Feb 21, 2018

Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woma…

AMEDA, INC.

FDA Devices Moderate Feb 21, 2018

Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to inser…

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega K…

Aesculap Implant Systems LLC

FDA Devices Moderate Feb 21, 2018

Norian Drillable Inject

Synthes USA

FDA Devices Moderate Feb 21, 2018

CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

DePuy Orthopaedics, Inc.

FDA Devices Moderate Feb 21, 2018

Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for…

Cook Inc.

FDA Devices Moderate Feb 21, 2018

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

Arrow International Inc

FDA Devices Moderate Feb 21, 2018

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a pa…

Zimmer Surgical Inc

FDA Devices Moderate Feb 21, 2018

Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed …

Cook Inc.

FDA Devices Moderate Feb 21, 2018

Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2

GE Medical Systems China Co., Ltd.

FDA Devices Moderate Feb 21, 2018

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system deve…

Siemens Medical Solutions USA, INC

FDA Devices Moderate Feb 21, 2018

BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine …

C.R. Bard, Inc.

FDA Devices Moderate Feb 21, 2018

Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Bat…

Cepheid

FDA Devices Moderate Feb 21, 2018

AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 21, 2018

ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,…

Aesculap Implant Systems LLC

FDA Devices Moderate Feb 21, 2018

Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia nee…

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Exactech, Inc.

FDA Devices Moderate Feb 21, 2018

BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blo…

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 21, 2018

Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABR…

Cook Inc.

FDA Devices Moderate Feb 21, 2018

Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies te…

Cincinnati Sub-Zero Products LLC

FDA Devices Moderate Feb 21, 2018

Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic …

Medtronic Neurosurgery

FDA Devices Moderate Feb 21, 2018

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intend…

ConforMIS, Inc.

FDA Devices Moderate Feb 21, 2018

Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical, Inc.

FDA Devices Moderate Feb 21, 2018

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pum…

Smiths Medical ASD, Inc.

FDA Devices Moderate Feb 21, 2018

JS Series SterilContainer S2 System

Aesculap Implant Systems LLC

FDA Devices Moderate Feb 21, 2018

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

GE Medical Systems China Co., Ltd.

CPSC Moderate Feb 21, 2018

Cost Plus World Market Recalls Bleeding Drip Taper Candles Due to Fire Hazard

Proud Wealth International LTD, of China

CPSC Moderate Feb 21, 2018

Outdoor Gas Fire Pits Recalled Due to Burn Hazard; Sold Exclusively at Home Depot; Made by Yayi

Zhejiang Yayi Metal Technology Co., Ltd. dba Yayi, of China

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