Use caution Drug recall · FDA · Published May 28, 2026

BD ChloraPrep Clear 1mL Applicator Recall: Risk of Contamination from Paper Lidding

BD recalls 60 ChloraPrep Clear 1mL applicators due to potential contamination from paper lidding wrinkles breaching the sterile seal. Affected lots have specific expiration dates and are sold by CareFusion 213, LLC.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0622-2026Drug BD ›

Use caution until it’s fixed

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Take action

Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000

✎ GovInfoNow plain-language explainer

BD is recalling 60 ChloraPrep Clear 1mL antiseptic applicators because paper lidding wrinkles might breach the sterile seal. This could lead to contamination during medical use, especially in surgeries or wound care. Read more at govinfonow.com/recall/31263-bd-chloraprep-clear-1ml-applicator-recall-risk-of-contamination-from.

Source Summary by GovInfoNow · govinfonow.com/recall/31263-bd-chloraprep-clear-1ml-applicator-recall-risk-of-contamination-from · Updated August 10, 2026 · FDA enforcement record: FDA #D-0622-2026

Cite this page

“BD ChloraPrep Clear 1mL Applicator Recall: Risk of Contamination from Paper Lidding.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31263-bd-chloraprep-clear-1ml-applicator-recall-risk-of-contamination-from. Based on FDA recall #D-0622-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0622-2026%22&limit=1).

The FDA announced on May 28, 2026, that CareFusion 213, LLC is recalling BD ChloraPrep Clear applicators due to a lack of assurance of sterility caused by wrinkles in the paper lidding. The agency stated the recall is voluntary and ongoing.

How to tell if you have it

Brand: BD
Product: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution
Company: CareFusion 213, LLC
NDC: 54365-400-31
Lot codes: 3201277; 3213912, 3214206, 3214914, 3215710, 3227485 (Exp 07/31/2026); 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318 (Exp 08/31/2026); 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956 (Exp 09/30/2026); 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562 (Exp 10/31/2026); 3321426 (Exp 11/30/2026); 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168 (Exp 12/31/2026); 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559 (Exp 1/31/2027); 4049128, 4060484, 4061622, 4062534 (Exp 02/28/2027); 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351 (Exp 03/31/2027); 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749 (Exp 04/30/2027); 4137704, 4139447 (Exp 05/31/2027)

The hazard

The recall involves a lack of assurance of sterility because wrinkles in the paper lidding may breach the seal area. According to the FDA, this defect could allow contamination of the sterile solution.

Context

GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), BD ChloraPrep Applicators Sterility Risk (2026-06-11), and CareFusion BD PurPrep Sterile Solution Recall (2026-04-22). Other recent recalls of similar products include B Braun 3000mL Sterile Saline Bags Recall (2026-04-02), Keystone DHP Topical Anesthetic Gel Recall (2026-05-21), and B Braun Lactated Ringer's Irrigation Bags Recall (2026-04-02).

How to tell if you have this one

Check for the product name 'ChloraPrep Clear 1mL Applicator' with 60 units. Look for lot numbers listed in the recall (e.g., 3201277, 3213912) and expiration dates from June 2026 through May 2027.

Brand
BD
Category
Drug

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Status
Ongoing
Distribution
Nationwide inthe USA, as well as other foreign distribution.

Recall number	Product, codes & lots	Quantity	Class	NDC
D-0622-2026	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.; Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559, Exp Date: 1/31/2027; Lot # 4049128, 4060484, 4061622, 4062534, Exp Date: 02/28/2027; Lot # 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351, Exp Date: 03/31/2027; Lot # 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749, Exp Date: 04/30/2027; Lot # 4137704, 4139447, Exp Date: 05/31/2027	N/A	Class II	54365-400-31
D-0623-2026	BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.; Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 3293922, 3297295, 3298930, 3299555, 3299562, 3301403, 3304245, 3306751, 3307190, 3310919, 3310926, 3314371, Exp Date: 10/31/2026; Lot # 3319520, 3321408, 3321409, 3324363, 3324369, 3332082, 3334305, 3335243, 3336896, 3337416, 3337417, 3340134, 3343540, 3346461, Exp Date: 11/30/2026; Lot # 3347121, 3350902, 3353143, 4004043, 4008394, 4009336, 4011488, 4012213, Exp Date: 12/31/2026; Lot # 4017668, 4019659, 4024538, 4025597, 4028103, 4030830, 4031885, 4032130, 4034194, 4037955, 4039988, 4039341, 4042520, 4045073, Exp Date: 01/31/2027; Lot # 4045127, 4050288, 4053896, 4058398, 4060624, 4062561, 4066133, 4068918, 4070112, 4074981, 4075814, 4078276, Exp Date: 02/28/2027; Lot # 4072390, 4073005, 4079088, 4080879, 4081625, 4086628, 4087806, 4096981, 4100347, 4100349, 4103385, 4103386, 4110975, 4113747, 4131843, Exp Date: 03/31/2027; Lot # 4121050, 4123171, 4123172, 4128501, 4128502, 4130512, 4135272, Exp Date: 04/30/2027; Lot # 4141597, 4150024, 4149611, 4150025, 4152202, 4157691, 4159978, 4160566, 4163121, Exp Date: 05/31/2027; Lot # 4173445, 4173447, 4178299, 4178303, 4180764, 4193574, 4197392, 4200111, 4204425, Exp Date: 06/30/2027; Lot # 4205156, 4206764, 4206766, 4207230, 4213335, 4211319, 4215668, 4218795, 4220980, 4242090, Exp Date: 07/31/2027; Lot # 4226396, 4227235, 4229934, 4232786, 4236636, 4236982, 4236489, 4242092, 4242505, 4248359, 4250795, 4254763, Exp Date: 08/31/2027; Lot # 4256132, 4260191, 4261289, 4261760, 4262812, 4269519, 4270776, 4271977, 4274445, 4276054, 4282861, Exp Date: 09/30/2027; Lot # 4284334, 4290362, 4291615, 4297871, 4299657, 4300686, 4302997, 4303204, 4305323, 4305318, 4310195, 4311615, 4312855, 4313930, Exp Date: 10/31/2027.	N/A	Class II	54365-400-30
D-0624-2026	BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.; Lot # 4032183, Exp 01/31/2027	193,440 applicators	Class I	54365-400-31
D-0625-2026	BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.; Lot # 4073005, Exp 03/31/2027	178,000 applicators	Class I	54365-400-30

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the packaging, which is listed in the recall (e.g., 3201277, 3213912).
Stop Using if Contaminated
If the paper lidding shows wrinkles or the seal appears compromised, stop using the applicator immediately.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide inthe USA, as well as other foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

May 28, 2026Firm started the recall
Jun 25, 2026FDA classified it Class II
Jul 1, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which lots are affected?

Affected lots include 3201277 (expiring June 2026), 3213912 (expiring July 2026), and many others through lot 4139447 (expiring May 2027).

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31263-bd-chloraprep-clear-1ml-applicator-recall-risk-of-contamination-from">BD ChloraPrep Clear 1mL Applicator Recall: Risk of Contamination from Paper Lidding (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0622-2026 (May 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0622-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.