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 8 critical, 41 moderate, and 1 lower-severity recalls. The page references 33 distinct recalling firms operating in 8 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (22), FDA Drug (12), NHTSA (7), 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 Devices Moderate Aug 1, 2018

AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 1, 2018

MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa¿ Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra

GE Medical Systems, LLC

FDA Devices Moderate Aug 1, 2018

Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

Life Technologies, Corp.

FDA Devices Moderate Aug 1, 2018

Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

Terumo Cardiovascular Systems Corp

FDA Devices Moderate Aug 1, 2018

Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pr

Medela Inc

FDA Devices Moderate Aug 1, 2018

OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid len

OMNIlife science Inc.

FDA Devices Low Aug 1, 2018

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Human Design Medical Llc

FDA Devices Moderate Aug 1, 2018

UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.

Philips Healthcare

FDA Devices Moderate Aug 1, 2018

Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.

Life Technologies, Corp.

FDA Devices Moderate Aug 1, 2018

Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.

Life Technologies, Corp.

FDA Devices Moderate Aug 1, 2018

Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 1, 2018

RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Aug 1, 2018

Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Forte Automation Systems Inc

FDA Devices Moderate Aug 1, 2018

cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morph

Roche Diagnostics Hematology

FDA Devices Moderate Aug 1, 2018

BLAST Bandage, sterile.

Tactical Medical Solutions, Inc.

FDA Devices Moderate Aug 1, 2018

Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.

Life Technologies, Corp.

FDA Devices Moderate Aug 1, 2018

Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.

Philips Healthcare

FDA Devices Moderate Aug 1, 2018

Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO

Guangzhou Improve Medical Instruments Co., Ltd.

FDA Devices Moderate Aug 1, 2018

PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

Bio-Rad Laboratories Inc

FDA Devices Moderate Aug 1, 2018

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.

Leica Microsystems, Inc.

FDA Devices Moderate Aug 1, 2018

HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy

Elekta, Inc.

FDA Devices Moderate Aug 1, 2018

Access Hi-Low Exam Tables, Model 6501-XX

Brewer Company, LLC

CPSC No agency class Aug 1, 2018

BMC Recalls Bicycles Due to Fall Hazard

BMC Switzerland AG, of Switzerland

CPSC No agency class Jul 31, 2018

Additional Incidents Prompt Johnson Health Tech to Reannounce Recall of Matrix Fitness Ascent Trainers and Ellipticals Due to Fire Hazard (Recall Alert)

NHTSA No agency class Jul 31, 2018

FREIGHTLINER,WESTERN STAR 2012-2015: STEERING:LINKAGES:TIE ROD ASSEMBLY

FREIGHTLINER,WESTERN STAR

USDA FSIS Moderate Jul 30, 2018

FSIS Issues Public Health Alert for Beef, Pork and Poultry Salad and Wrap Products due to Concerns about Contamination with Cyclospora

Caito Foods, LLC

NHTSA No agency class Jul 29, 2018

MERCEDES-BENZ 2017-2018: POWER TRAIN:DRIVELINE:DRIVESHAFT

MERCEDES-BENZ

CPSC No agency class Jul 27, 2018

Hirsch Gift Recalls Wireless Charging Pads Due to Burn Hazard

NHTSA No agency class Jul 27, 2018

GENESIS 2018: AIR BAGS:SENSOR:OCCUPANT CLASSIFICATION

GENESIS

NHTSA No agency class Jul 27, 2018

RAM 2015-2017: STRUCTURE:BODY:TAILGATE

RAM

CPSC No agency class Jul 26, 2018

Jimmy Hack Golf Recalls Golf Swing Trainers Due to Injury Hazard

Jimmy Hack Golf LLC, of Easley, S.C.

CPSC No agency class Jul 26, 2018

Trek Recalls Bontrager Line Pro Bicycle Pedals Due to Fall Hazard

Trek Bicycle Corporation, of Waterloo, Wis.

NHTSA No agency class Jul 26, 2018

JEEP 2018: POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT

JEEP

NHTSA No agency class Jul 26, 2018

CHRYSLER 2018: POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT

CHRYSLER

NHTSA No agency class Jul 26, 2018

CHRYSLER,JEEP 2018-2019: POWER TRAIN:AUTOMATIC TRANSMISSION

CHRYSLER,JEEP

FDA Food Moderate Jul 25, 2018

TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 10599 6, 7.5 Lbs. (3 x 2.5 Lbs. Bags), Best Kept Between 34¿F and 40¿F <50% Relative Humidity

T R Toppers, Inc.

FDA Food Moderate Jul 25, 2018

Odwalla Superfood fruit smoothie 15.2 oz. (450mL) plastic bottle; Sold in 8 pack case Unit UPC: 000-14054-06405-5 Odwalla Life Food- Canada only - Unit UPC: 000-14054-03125-5 Ingredients: Apple Juice from concentrate, peach and mango purees from concentrate, banana puree, less than 1% OF, Spirulina, natural flavors, lemon juice concentrate (for tartness) vitamin C (ascorbic acid) kale, wheat grass, barley grass, wheat sprouts, Jerusalem artichoke, Nova Scotia dulse Pectin and gellan gu

The Coca-Cola Company

FDA Food Critical Jul 25, 2018

Naked Bread Hamburger Buns #NothingToHide, 8 pack. Product is packaged in low density polyethylene bag and identified as Naked Bread Hamburger Buns #NothingToHide, Net wt. 16.5 oz., UPC #72220 11075. The label is read in parts: "***INGREDIENTS: ENRICHED UNBLEACHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN AND FOLIC ACID(, WATER, YEAST, SUGAR, VITAL WHEAT GLUTEN, PALM OIL*** CONTAINS: WHEAT***".

United States Bakery Corp

FDA Drug Moderate Jul 25, 2018

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

La Vita Compounding Pharmacy, LLC

FDA Drug Moderate Jul 25, 2018

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

Avella of Deer Valley, Inc. Store 38

FDA Drug Moderate Jul 25, 2018

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25

Avella of Deer Valley, Inc. Store 38

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.