PlainRecalls

2013 Recalls

6,215 recalls · Page 104 of 125

2013 Recall Year Insight

Federal agencies issued 6,215 product recalls indexed by PlainRecalls in calendar year 2013. That represents about 7.40% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.0 recalls per day across the FDA, CPSC, 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 125 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 2013.

On this page of 50 records, severity classification shows 0 critical, 38 moderate, and 12 lower-severity recalls. The page references 27 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (34), FDA Drug (16), 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 2013 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Apr 3, 2013

SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each)…

CareFusion 213, LLC

FDA Drug Moderate Apr 3, 2013

Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count …

CareFusion 213, LLC

FDA Drug Moderate Apr 3, 2013

Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmace…

West-ward Pharmaceutical Corp.

FDA Drug Low Apr 3, 2013

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE,…

Hill Dermaceuticals, Inc.

FDA Drug Low Apr 3, 2013

PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, D…

L. Perrigo Co.

FDA Drug Moderate Apr 3, 2013

Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10…

Hospira Inc.

FDA Drug Moderate Apr 3, 2013

SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFus…

CareFusion 213, LLC

FDA Drug Moderate Apr 3, 2013

PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08

Physicians Total Care, Inc.

FDA Drug Low Apr 3, 2013

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT f…

Pfizer Inc.

FDA Drug Moderate Apr 3, 2013

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distribu…

Zydus Pharmaceuticals USA Inc

FDA Drug Low Apr 3, 2013

Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Hospira, Inc.

FDA Drug Low Apr 3, 2013

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150…

Hill Dermaceuticals, Inc.

FDA Drug Moderate Apr 3, 2013

FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packag…

CareFusion 213, LLC

FDA Drug Moderate Apr 3, 2013

PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09

Physicians Total Care, Inc.

FDA Drug Moderate Apr 3, 2013

SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicator…

CareFusion 213, LLC

FDA Drug Moderate Apr 3, 2013

Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged i…

CareFusion 213, LLC

FDA Devices Moderate Apr 3, 2013

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Mindray DS USA, Inc. d.b.a. Mindray North America

FDA Devices Moderate Apr 3, 2013

VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W…

Biomerieux Inc

FDA Devices Moderate Apr 3, 2013

Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 3, 2013

Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument…

Synthes USA HQ, Inc.

FDA Devices Moderate Apr 3, 2013

Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medicatio…

CareFusion Corporation

FDA Devices Moderate Apr 3, 2013

Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requirin…

Smiths Medical ASD, Inc.

FDA Devices Moderate Apr 3, 2013

Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

Orthohelix Surgical Designs Inc

FDA Devices Moderate Apr 3, 2013

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

Advanced Sterilization Products

FDA Devices Moderate Apr 3, 2013

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Cou…

Cardinal Health

FDA Devices Moderate Apr 3, 2013

bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Strept…

Biomerieux Inc

FDA Devices Low Apr 3, 2013

Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Apr 3, 2013

Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedu…

Medtronic Inc. Cardiac Rhythm Disease Management

FDA Devices Moderate Apr 3, 2013

Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product …

Medtronic Inc. Cardiac Rhythm Disease Management

FDA Devices Moderate Apr 3, 2013

VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W…

Biomerieux Inc

FDA Devices Moderate Apr 3, 2013

BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc…

Becton Dickinson & Co.

FDA Devices Moderate Apr 3, 2013

Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30…

Cardinal Health

FDA Devices Low Apr 3, 2013

Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to …

Cooper Surgical, Inc.

FDA Devices Low Apr 3, 2013

Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into…

Cooper Surgical, Inc.

FDA Devices Moderate Apr 3, 2013

Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Count…

Cardinal Health

FDA Devices Moderate Apr 3, 2013

20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV E…

Biosense Webster, Inc.

FDA Devices Moderate Apr 3, 2013

VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (r…

Biomerieux Inc

FDA Devices Moderate Apr 3, 2013

Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The…

Vital Images, Inc.

FDA Devices Low Apr 3, 2013

Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the v…

Cooper Surgical, Inc.

FDA Devices Moderate Apr 3, 2013

Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Di…

Cardinal Health

FDA Devices Low Apr 3, 2013

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the…

Cooper Surgical, Inc.

FDA Devices Moderate Apr 3, 2013

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

Cooper Surgical, Inc.

FDA Devices Moderate Apr 3, 2013

Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Co…

Cardinal Health

FDA Devices Moderate Apr 3, 2013

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA7…

Cardinal Health

FDA Devices Moderate Apr 3, 2013

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

Toshiba American Medical Systems Inc

FDA Devices Moderate Apr 3, 2013

Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Coun…

Cardinal Health

FDA Devices Moderate Apr 3, 2013

KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that …

Kimberly-Clark Corporation

FDA Devices Moderate Apr 3, 2013

Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA…

Genetic Testing Institute,inc

FDA Devices Low Apr 3, 2013

Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to funct…

Cooper Surgical, Inc.

FDA Devices Low Apr 3, 2013

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the …

Cooper Surgical, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2013 with 2012 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA — consumer product and vehicle recall feeds for 2013