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, 36 moderate, and 6 lower-severity recalls. The page references 14 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (37), FDA Drug (11), FDA Food (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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Food Critical Sep 19, 2018

Fuzhou Fish Balls, packaged in a blue and white package bag, in two sizes: Net WT: 14 OZ (400g), UPC: 6 953640 05000 and Net WT:4.5 lbs. (2043g), UPC: 6 953640 050017. Keep Frozen.

H & C Food Inc.

FDA Food Critical Sep 19, 2018

Salad Mix (Green Kale, Green Cabbage, Broccoli Stems, Chicory, and Brussel Sprouts)

Air Stream Corp.

FDA Drug Critical Sep 19, 2018

Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02

Hellolife

FDA Drug Critical Sep 19, 2018

Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.

Accord Healthcare, Inc.

FDA Drug Low Sep 19, 2018

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Pfizer Inc.

FDA Drug Low Sep 19, 2018

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Mylan Pharmaceuticals Inc.

FDA Drug Critical Sep 19, 2018

Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02

Hellolife

FDA Drug Critical Sep 19, 2018

Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.

SCA Pharmaceuticals, Inc.

FDA Drug Critical Sep 19, 2018

Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02

Hellolife

FDA Drug Critical Sep 19, 2018

Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02

Hellolife

FDA Drug Low Sep 19, 2018

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709

United Therapeutics Corp.

FDA Drug Low Sep 19, 2018

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

Mylan Pharmaceuticals Inc.

FDA Drug Low Sep 19, 2018

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Par Pharmaceutical, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280

Zimmer Biomet, Inc.

FDA Devices Low Sep 19, 2018

VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Ortho-Clinical Diagnostics

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery.

Beaver Visitec

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

Diagnostica Stago, Inc.

FDA Devices Moderate Sep 19, 2018

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320

Zimmer Biomet, 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.