PlainRecalls

2018 Recalls

6,355 recalls · Page 37 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 4 critical, 46 moderate, and 0 lower-severity recalls. The page references 14 distinct recalling firms operating in 2 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), NHTSA (4), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pu…

Cardiovascular Systems Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M00…

Stryker Neurovascular

FDA Devices Moderate Sep 19, 2018

AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or …

LeMaitre Vascular, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 440 mm, Item Number: 814411440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 380 mm, Item Number: 814409380

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 320 mm, Item Number: 814509320

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm, Item Number: 814511420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

remel THIOGLYCOLLATE MEDIUM, REF 05152

Remel Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-…

Ohio Medical Corporation

FDA Devices Moderate Sep 19, 2018

da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, for…

Intuitive Surgical, Inc.

FDA Devices Moderate Sep 19, 2018

Vascular Solutions Venture Rx Catheter, 6F, resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 280 mm, Item Number: 814409280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 340 mm, Item Number: 814509340

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) …

Diagnostica Stago, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm, Item Number: 814611340

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Moderate Sep 19, 2018

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.

SPS Sterilization, Inc

FDA Devices Moderate Sep 19, 2018

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neu…

Vascular Technology, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm, Item Number: 814313280

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm, Item Number: 814511440

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm, Item Number: 814313440

Zimmer Biomet, Inc.

NHTSA Critical Sep 19, 2018

INTERNATIONAL 2019: EXTERIOR LIGHTING:BRAKE LIGHTS

INTERNATIONAL

NHTSA Critical Sep 14, 2018

ALFA ROMEO 2017-2018: ELECTRICAL SYSTEM:WIRING

ALFA ROMEO

NHTSA Critical Sep 14, 2018

ALFA ROMEO 2018-2019: ENGINE AND ENGINE COOLING:COOLING SYSTEM:HOSES/LINES/PIPING/FITTINGS

ALFA ROMEO

NHTSA Critical Sep 14, 2018

BENTLEY 2018: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

BENTLEY

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018