2018 Recalls
7,717 recalls · Page 74 of 155
2018 Recall Year Insight
Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 9.19% of the 83,949 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, 50 moderate, and 0 lower-severity recalls. The page references 20 distinct recalling firms operating in 3 distinct product categories, with 45 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.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
St Jude Medical Inc.
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a va…
Horiba Instruments, Inc dba Horiba Medical
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK Immu…
BioMerieux SA
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256,…
St Jude Medical Inc.
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Philips Ingenuity Core 728321
Philips Medical Systems (Cleveland) Inc
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Randox Laboratories Ltd.
Ingenuity Core128 728323
Philips Medical Systems (Cleveland) Inc
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230…
St Jude Medical Inc.
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with…
B. Braun Medical, Inc.
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 1…
St Jude Medical Inc.
Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Teleflex Medical Europe Ltd
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100…
St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369…
St Jude Medical Inc.
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Safe N Simple, LLC
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
ImagePilot, Model No. D9MA
Konica Minolta Medical Imaging USA, Inc.
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-30…
St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636;…
St Jude Medical Inc.
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the …
Toshiba American Medical Systems Inc
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742…
St Jude Medical Inc.
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in…
Zimmer Biomet, Inc.
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Ion Beam Applications S.A.
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Cl…
Cenorin, LLC
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Philips Medical Systems Nederlands
Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Single Chamber Temporary External Pacemaker, Model 53401
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Ingenuity TF PET/CT 882442
Philips Medical Systems (Cleveland) Inc
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
Randox Laboratories Ltd.
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; …
St Jude Medical Inc.
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
Intersurgical Inc
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Philips Medical Systems Nederlands
Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
Exsurco Medical
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100…
St Jude Medical Inc.
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100…
St Jude Medical Inc.
Ingenuity Core128/Elite China 728324
Philips Medical Systems (Cleveland) Inc
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for tr…
RAYSEARCH LABORATORIES AB
Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
Siemens Medical Solutions USA, Inc
BRP Recalls All-Terrain Vehicles Due to Fuel Leak and Fire Hazard (Recall Alert)
Helmets R Us Recalls Helmets Due to Risk of Head Injury (Recall Alert)
Strategic Sports Ltd., of Hong Kong
Nearby Recall Years
Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.
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
Read our methodology — how this data is sourced, computed, and verified.