PlainRecalls

Cook Incorporated

Compiled from official public sources by the editorial team.

85 recalls on record · Latest: May 13, 2026

Cook Incorporated Recall Insight

Cook Incorporated appears on 85 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.084% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 13, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 35 entries, severity tagging shows 0 critical, 35 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 35 of 35 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (35). The date window on this page runs from Jun 15, 2022 to Oct 5, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 5, 2022

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G0…

FDA Devices Moderate Oct 5, 2022

Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)

FDA Devices Moderate Oct 5, 2022

Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476

FDA Devices Moderate Oct 5, 2022

Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DO…

FDA Devices Moderate Oct 5, 2022

Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 P…

FDA Devices Moderate Oct 5, 2022

Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

FDA Devices Moderate Oct 5, 2022

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G3413…

FDA Devices Moderate Oct 5, 2022

Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

FDA Devices Moderate Oct 5, 2022

Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691)…

FDA Devices Moderate Oct 5, 2022

Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033

FDA Devices Moderate Oct 5, 2022

Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

FDA Devices Moderate Oct 5, 2022

Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)

FDA Devices Moderate Oct 5, 2022

Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621…

FDA Devices Moderate Oct 5, 2022

Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678

FDA Devices Moderate Oct 5, 2022

Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914

FDA Devices Moderate Oct 5, 2022

Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 …

FDA Devices Moderate Oct 5, 2022

Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

FDA Devices Moderate Oct 5, 2022

Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter position…

FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and e…

FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and e…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter position…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positio…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positionin…

FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and ex…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positio…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positionin…

FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioni…

FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter position…

FDA Devices Moderate Jul 20, 2022

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

FDA Devices Moderate Jun 15, 2022

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NEST…

FDA Devices Moderate Jun 15, 2022

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE…

FDA Devices Moderate Jun 15, 2022

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.