Ethicon Endo-Surgery Inc: PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.

Recall number

Z-2610-2014

Recalling firm

Ethicon Endo-Surgery Inc

Product

PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.

Status

Terminated

Initiated

2014-08-12

Posted

2014-09-08

Terminated

2015-07-10

Reason

The device may have a non-conforming component that may cause the device to fire an unformed staple.

Root cause

Nonconforming Material/Component

Action

The firm, Ethicon Endo-Surgery, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 25, 2014 to its customers via overnight, UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory to determine if you have recalled product on hand; remove the recalled product and communicate the issue to relevent staff; complete and return Business Reply Form (BRF) confirming receipt of this notice within three (3) business days, indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. The BRF may be sent to Stericycle by fax at 1-855-328-6659 or by email at ethicon3022@stericycle.com. Product replacement is available for customers who return unopened affected product. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266). If you need additional shipping labels or a communications package, contact Stericycle at 1-855-328-0398 and reference Event 3022.

Quantity

42,798

Distribution

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.

Lot, serial or model codes

PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87  PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch  L4EG2T L4EH20 L4EH85 L4EK50 L4EN58 L4EN94 L4EP2F L4EP6G L4ER1L L4EU0J L4EV07  Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch  L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V  Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch  L90W40 L90X3C L90Y0U L90Y4V L90Z7C L9108Z L91151 L91223 L91970 L91A7N L91C5C L91E2Z L91E6P L91G46 L91J4L L91K3A L91M4U L91T81

510(k) numbers

not on file

PMA numbers

not on file

Product code

GAG

Firm FEI

1527736

Firm city

Blue Ash

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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