PlainRecalls

2012 Recalls

3,552 recalls · Page 20 of 72

2012 Recall Year Insight

Federal agencies issued 3,552 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.23% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 9.7 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 72 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 2012.

On this page of 50 records, severity classification shows 3 critical, 46 moderate, and 1 lower-severity recalls. The page references 17 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (17), 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 2012 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 Oct 31, 2012

Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle,…

Raritan Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2012

Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispe…

Watson Laboratories Inc

FDA Drug Moderate Oct 31, 2012

Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merch…

Raritan Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2012

Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only,…

Bristol-myers Squibb Company

FDA Drug Moderate Oct 31, 2012

CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 028…

Raritan Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2012

Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

FDA Drug Moderate Oct 31, 2012

Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** …

Mylan Pharmaceuticals Inc.

FDA Drug Low Oct 31, 2012

Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O.…

Abc Compounding Company Inc

FDA Drug Moderate Oct 31, 2012

Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispens…

Watson Laboratories Inc

FDA Drug Moderate Oct 31, 2012

Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Disp…

Watson Laboratories Inc

FDA Drug Moderate Oct 31, 2012

DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.

Raritan Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2012

Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-4098…

Raritan Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2012

Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carto…

Watson Laboratories Inc

FDA Drug Moderate Oct 31, 2012

Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by:…

Raritan Pharmaceuticals, Inc.

FDA Drug Critical Oct 31, 2012

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx o…

Hospira Inc.

FDA Drug Moderate Oct 31, 2012

Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distr…

Raritan Pharmaceuticals, Inc.

FDA Drug Critical Oct 31, 2012

BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufact…

Bristol-myers Squibb Company

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-…

Westmed Inc

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for …

GE Healthcare, LLC

FDA Devices Moderate Oct 31, 2012

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to…

Biomet 3i, LLC

FDA Devices Moderate Oct 31, 2012

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to…

Nipro Medical Corporation

FDA Devices Moderate Oct 31, 2012

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection,…

GE Healthcare, LLC

FDA Devices Moderate Oct 31, 2012

AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseud…

Advandx Inc

FDA Devices Moderate Oct 31, 2012

Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hou…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for…

GE Healthcare, LLC

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotat…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to …

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arter…

Westmed Inc

FDA Devices Moderate Oct 31, 2012

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to in…

Nipro Medical Corporation

FDA Devices Moderate Oct 31, 2012

GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to …

GE Healthcare, LLC

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotat…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directio…

Greatbatch Medical

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to …

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, b…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, …

Westmed Inc

FDA Devices Moderate Oct 31, 2012

EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat O…

Ethicon, Inc.

FDA Devices Moderate Oct 31, 2012

Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue Sys…

Optovue Inc.

FDA Devices Moderate Oct 31, 2012

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. …

Westmed Inc

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for v…

GE Healthcare, LLC

FDA Devices Critical Oct 31, 2012

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Cost…

Hospira Inc.

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to…

Nipro Medical Corporation

FDA Devices Moderate Oct 31, 2012

DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use …

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-…

Westmed Inc

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Oct 31, 2012

Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on…

Terumo Cardiovascular Systems Corporation

Nearby Recall Years

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

Compare 2012 with 2011 →

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 2012