PlainRecalls

2018 Recalls

6,355 recalls · Page 72 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 1 critical, 48 moderate, and 1 lower-severity recalls. The page references 20 distinct recalling firms operating in 5 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (42), FDA Drug (8), 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 Drug Moderate May 23, 2018

Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia,…

Prescript Pharmaceuticals, Inc.

FDA Drug Moderate May 23, 2018

B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Milbar Laboratories, Inc.

FDA Drug Critical May 23, 2018

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedic…

AuroMedics Pharma LLC

FDA Drug Moderate May 23, 2018

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62…

L. Perrigo Company

FDA Drug Moderate May 23, 2018

Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc…

Prescript Pharmaceuticals, Inc.

FDA Drug Low May 23, 2018

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

Boiron Inc.

FDA Drug Moderate May 23, 2018

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

Milbar Laboratories, Inc.

FDA Drug Moderate May 23, 2018

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philade…

Sun Pharmaceutical Industries, Inc.

FDA Devices Moderate May 23, 2018

BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

Epic Extremity, LLC

FDA Devices Moderate May 23, 2018

(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item numb…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS3181…

Draegar Medical Systems, Inc.

FDA Devices Moderate May 23, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

Kelyniam Global, Inc.

FDA Devices Moderate May 23, 2018

(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and End…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

Epic Extremity, LLC

FDA Devices Moderate May 23, 2018

BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered r…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) Th…

Invivo Corporation

FDA Devices Moderate May 23, 2018

iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic …

Beckman Coulter Inc.

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.

Zimmer Biomet, Inc.

FDA Devices Moderate May 23, 2018

BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titan…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of ti…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control …

Tosoh Bioscience Inc

FDA Devices Moderate May 23, 2018

Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) Product Usage: The Endo GIA unive…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

Micro-Tech (Nanjing) Co., Ltd.

FDA Devices Moderate May 23, 2018

Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA univers…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagger…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titani…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) Product Usage: The Endo GIA unive…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.

Zimmer Biomet, Inc.

FDA Devices Moderate May 23, 2018

BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of tit…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GIA u…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 23, 2018

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Richard Wolf GmbH

FDA Devices Moderate May 23, 2018

DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with …

Rockwell Medical, Inc

FDA Devices Moderate May 23, 2018

BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagge…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

Kelyniam Global, Inc.

FDA Devices Moderate May 23, 2018

SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 23, 2018

Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radi…

Visaris DOO

FDA Devices Moderate May 23, 2018

Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.

Zimmer Biomet, Inc.

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-s…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITD…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018