PlainRecalls

2012 Recalls

Compiled from official public sources by the editorial team.

4,173 recalls · Page 11 of 84

2012 Recall Year Insight

Federal agencies issued 4,173 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.10% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 11.4 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 84 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 2 critical, 48 moderate, and 0 lower-severity recalls. The page references 20 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Softw…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimen…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundari…

Mako Surgical Corporation

FDA Devices Moderate Nov 28, 2012

GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

GE Healthcare, LLC

FDA Devices Moderate Nov 28, 2012

Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: Th…

Biomet, Inc.

FDA Devices Moderate Nov 28, 2012

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20…

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in…

Beckman Coulter Inc.

FDA Devices Moderate Nov 28, 2012

Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head …

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance…

Innovative Magnetic Resonance Imaging Systems Inc.

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, ca…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumb…

KCI USA, Inc.

FDA Devices Moderate Nov 28, 2012

GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.

GE Healthcare, LLC

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, …

Superstat Corp

FDA Devices Critical Nov 28, 2012

Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device u…

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

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the cli…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Nov 28, 2012

Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www…

Stryker Spine

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, cat…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture li…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software upda…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Produ…

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in …

Superstat Corp

FDA Devices Moderate Nov 28, 2012

0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is anal…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are …

Kerr Corporation

FDA Devices Moderate Nov 28, 2012

00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provision…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, i…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 S…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign…

Sentec AG

FDA Devices Moderate Nov 28, 2012

Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means …

Biomet 3i, LLC

FDA Devices Moderate Nov 28, 2012

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Nov 28, 2012

6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

Gyrus Acmi, Incorporated

FDA Devices Moderate Nov 28, 2012

7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn …

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatmen…

Carl Zeiss Meditec, Inc.

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in …

Superstat Corp

FDA Devices Moderate Nov 28, 2012

7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens…

Biomerieux Inc

FDA Devices Critical Nov 28, 2012

Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device…

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

FDA Devices Moderate Nov 28, 2012

. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisi…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quan…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 28, 2012

7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

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 - consumer product and vehicle recall feeds for 2012

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 2012 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.