PlainRecalls

2013 Recalls

6,262 recalls · Page 36 of 126

2013 Recall Year Insight

Federal agencies issued 6,262 product recalls indexed by PlainRecalls in calendar year 2013. That represents about 6.16% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 17.2 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 126 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 1 critical, 47 moderate, and 2 lower-severity recalls. The page references 29 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 (35), FDA Drug (15), 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 Nov 13, 2013

Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 0854…

Sandoz, Inc

FDA Drug Moderate Nov 13, 2013

Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH,…

West-Ward Pharmaceutical Corp.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Myla…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subs…

Amgen, Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., ND…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal P…

Amneal Pharmaceuticals of New York, LLC.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, ND…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., ND…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Myla…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, My…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labele…

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Nov 13, 2013

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospir…

Hospira Inc.

FDA Devices Moderate Nov 13, 2013

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

Smith & Nephew Inc

FDA Devices Moderate Nov 13, 2013

Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in ra…

Elekta, Inc.

FDA Devices Moderate Nov 13, 2013

Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-F…

Zimmer, Inc.

FDA Devices Moderate Nov 13, 2013

VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrad…

Vital Images, Inc.

FDA Devices Moderate Nov 13, 2013

HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Ren…

Hamilton Medical, Inc.

FDA Devices Moderate Nov 13, 2013

Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…

Ethicon Endo-Surgery Inc

FDA Devices Moderate Nov 13, 2013

CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to …

Carestream Health Inc.

FDA Devices Moderate Nov 13, 2013

Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for conti…

Richard Wolf Medical Instruments Corp.

FDA Devices Moderate Nov 13, 2013

DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to pe…

Carestream Health Inc.

FDA Devices Moderate Nov 13, 2013

DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is d…

Carestream Health Inc.

FDA Devices Moderate Nov 13, 2013

MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illuminati…

Insight Instruments, Inc.

FDA Devices Low Nov 13, 2013

da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacem…

Intuitive Surgical, Inc.

FDA Devices Critical Nov 13, 2013

Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K1…

Baylis Medical Corp *

FDA Devices Moderate Nov 13, 2013

Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.…

ITC-Nexus Dx

FDA Devices Moderate Nov 13, 2013

ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in sample…

Beckman Coulter Inc.

FDA Devices Moderate Nov 13, 2013

UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hema…

Beckman Coulter Inc.

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indica…

Smiths Medical ASD, Inc.

FDA Devices Low Nov 13, 2013

Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

Helix Medical LLC

FDA Devices Moderate Nov 13, 2013

Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: E…

Edwards Lifesciences, LLC

FDA Devices Moderate Nov 13, 2013

Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland…

Medtronic Vascular, Inc.

FDA Devices Moderate Nov 13, 2013

S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary byp…

Sorin Group Deutschland GmbH

FDA Devices Moderate Nov 13, 2013

Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospi…

Steris Corporation

FDA Devices Moderate Nov 13, 2013

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Smith & Nephew Inc

FDA Devices Moderate Nov 13, 2013

Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise in…

Smiths Medical ASD, Inc.

FDA Devices Moderate Nov 13, 2013

Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

Pinook-Usa

FDA Devices Moderate Nov 13, 2013

ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes i…

Beckman Coulter Inc.

FDA Devices Moderate Nov 13, 2013

Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunct…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicat…

Smiths Medical ASD, Inc.

FDA Devices Moderate Nov 13, 2013

Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile …

Smiths Medical ASD, Inc.

FDA Devices Moderate Nov 13, 2013

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250…

SEPPIM SAS

FDA Devices Moderate Nov 13, 2013

Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…

Ethicon Endo-Surgery Inc

FDA Devices Moderate Nov 13, 2013

Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band …

Ethicon Endo-Surgery Inc

FDA Devices Moderate Nov 13, 2013

Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.

Pinook-Usa

FDA Devices Moderate Nov 13, 2013

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indica…

Smiths Medical ASD, Inc.

FDA Devices Moderate Nov 13, 2013

pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold indivi…

Mesa Laboratories, 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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2013 across the FDA, CPSC 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 July 2026.