PlainRecalls

2012 Recalls

3,552 recalls · Page 8 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 2 critical, 47 moderate, and 1 lower-severity recalls. The page references 16 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, NHTSA, or USDA FSIS 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

6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provision…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazili…

Biomerieux Inc

FDA Devices Low Nov 28, 2012

Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intend…

Horiba Instruments, Inc dba Horiba Medical

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Softw…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

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

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

Vital Signs Colorado Inc.

FDA Devices Moderate Nov 28, 2012

7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50k…

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffuse…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 S…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 …

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 So…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: L…

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 So…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

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

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 S…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic de…

Beckman Coulter Inc.

FDA Devices Moderate Nov 28, 2012

6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 …

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixati…

Captiva Spine, Inc

FDA Devices Moderate Nov 28, 2012

SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specia…

Stryker Spine

FDA Devices Moderate Nov 28, 2012

Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 S…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

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

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic …

Biomet 3i, LLC

FDA Devices Moderate Nov 28, 2012

00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slo…

Zimmer, Inc.

FDA Devices Critical Nov 28, 2012

ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 S…

Ethicon, Inc.

FDA Devices Moderate Nov 28, 2012

Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long L…

Kerr Corporation

FDA Devices Moderate Nov 28, 2012

S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants …

SpineFrontier, Inc.

FDA Devices Moderate Nov 28, 2012

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Produc…

King Systems Corp.

FDA Devices Moderate Nov 28, 2012

IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and…

Extremity Medical LLC

FDA Devices Moderate Nov 28, 2012

6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software u…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely…

Superstat Corp

FDA Devices Moderate Nov 28, 2012

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

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software up…

Biomerieux Inc

FDA Devices Moderate Nov 28, 2012

Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obta…

Vital Signs Devices, a GE Healthcare Company

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software up…

Biomerieux Inc

FDA Devices Critical Nov 28, 2012

ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorb…

Ethicon, Inc.

FDA Devices Moderate Nov 28, 2012

UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic de…

Beckman Coulter Inc.

FDA Devices Moderate Nov 28, 2012

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

NuVasive Inc

FDA Devices Moderate Nov 28, 2012

Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplast…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 S…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cement…

Zimmer, Inc.

FDA Devices Moderate Nov 28, 2012

Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous …

SpineFrontier, 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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2012