PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 recalls per day across the FDA, CPSC, USDA FSIS, 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 159 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 22 distinct recalling firms operating in 3 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (47), FDA Drug (3), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Apr 4, 2018

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

Paddock Laboratories, LLC.

FDA Drug Moderate Apr 4, 2018

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Amneal Pharmaceuticals

FDA Drug Moderate Apr 4, 2018

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Apollo Care

FDA Devices Moderate Apr 4, 2018

AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

COACH¿ Self-Adhering Sports Wrap (size: 2in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.

Becton Dickinson & Company

FDA Devices Moderate Apr 4, 2018

First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

Madison Polymeric Engineering

FDA Devices Moderate Apr 4, 2018

IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588

Konica Minolta Medical Imaging USA, Inc.

FDA Devices Moderate Apr 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

Encore Medical, Lp

FDA Devices Moderate Apr 4, 2018

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Johnson & Johnson Vision Care, Inc.

FDA Devices Moderate Apr 4, 2018

Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

Covidien LLC

FDA Devices Moderate Apr 4, 2018

Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652;

DePuy Orthopaedics, Inc.

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with s

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

Encore Medical, Lp

FDA Devices Moderate Apr 4, 2018

Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

Cook Inc.

FDA Devices Moderate Apr 4, 2018

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

GE Healthcare, LLC

FDA Devices Moderate Apr 4, 2018

Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer blo

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Johnson & Johnson Vision Care, Inc.

FDA Devices Moderate Apr 4, 2018

PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

Allen Medical Systems

FDA Devices Moderate Apr 4, 2018

11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

Roche Molecular Systems, Inc.

FDA Devices Moderate Apr 4, 2018

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric in

ConMed Corporation

FDA Devices Moderate Apr 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

Encore Medical, Lp

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal ar

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is add

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.

Covidien LLC

FDA Devices Moderate Apr 4, 2018

1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H TROC NAIL 320X11X125 STER L H TROC NAIL 340X11X125 STER L H TROC NAIL 360X11X125 STER L H TROC NAIL 380X11X125 STER L H TROC NAIL 400X11X125 STER L H TROC NAIL 420X11X125 STER L H TROC NAIL 440X11X125 STER L H TROC

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

Cook Inc.

FDA Devices Moderate Apr 4, 2018

Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

Encore Medical, Lp

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated wi

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, patho

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE 800508345 NAIL TIB DYN 08X34.5 - STERILE 800508360 NAIL TIB DYN 08X36.0 - STERILE 800508375 NAIL TIB DYN 08X37.5 - STERILE 800508390 NAIL TIB DYN 08X39.0 - STERILE 800508405

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

Medical Components, Inc dba MedComp

FDA Devices Moderate Apr 4, 2018

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

Teleflex Medical

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM STERILE The Trochanteric Nail System is inten

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

GETINGE US SALES LLC

FDA Devices Moderate Apr 4, 2018

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

Johnson & Johnson Vision Care, 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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2018

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.