PlainRecalls

2018 Recalls

6,355 recalls · Page 60 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 3 critical, 42 moderate, and 5 lower-severity recalls. The page references 18 distinct recalling firms operating in 5 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (29), FDA Drug (20), FDA Food (1), 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 Food Critical Jul 11, 2018

Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Whole Foods/ Ama…

Caito Foods Service, Inc.

FDA Drug Moderate Jul 11, 2018

eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured Fo…

Eb5 Corporation

FDA Drug Low Jul 11, 2018

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bot…

LUPIN SOMERSET

FDA Drug Moderate Jul 11, 2018

Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Critical Jul 11, 2018

Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Ser…

Fagron Compounding Services LLC dba Fagron Sterile Services

FDA Drug Low Jul 11, 2018

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Qualgen, LLC

FDA Drug Moderate Jul 11, 2018

Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Moderate Jul 11, 2018

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC,…

Ingenus Pharmaceuticals Llc

FDA Drug Moderate Jul 11, 2018

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Critical Jul 11, 2018

Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Ser…

Fagron Compounding Services LLC dba Fagron Sterile Services

FDA Drug Moderate Jul 11, 2018

Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Drug Low Jul 11, 2018

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Qualgen, LLC

FDA Drug Moderate Jul 11, 2018

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, …

Ingenus Pharmaceuticals Llc

FDA Drug Moderate Jul 11, 2018

Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC

FDA Devices Moderate Jul 11, 2018

da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System …

Intuitive Surgical, Inc.

FDA Devices Moderate Jul 11, 2018

GE Healthcare CARESCAPE Monitor B650

GE Healthcare Finland Oy

FDA Devices Moderate Jul 11, 2018

microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754

Medtronic Inc.

FDA Devices Moderate Jul 11, 2018

Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

Beaver Visitec

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 11, 2018

microTargeting" Drive System, Product Number MT-DS

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

LFIT Anatomic CoCr Femoral Heads, 6260-9-036

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 11, 2018

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00

Zimmer Biomet, Inc.

FDA Devices Low Jul 11, 2018

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping cas…

ECOLAB INC

FDA Devices Moderate Jul 11, 2018

microTargeting" Drive System, Product Number 66-ZD-MD

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 11, 2018

Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

Trilliant Surgical Ltd.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

FHC, Inc.

FDA Devices Low Jul 11, 2018

ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping ca…

ECOLAB INC

FDA Devices Moderate Jul 11, 2018

microTargeting" Drive System, Product Number MT-DS-01

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144

Howmedica Osteonics Corp.

FDA Devices Moderate Jul 11, 2018

microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

FHC, Inc.

FDA Devices Moderate Jul 11, 2018

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

B. Braun Medical, Inc.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 11, 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

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