FDA Medical Device Recalls (openFDA)
Stryker Corporation: SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
- Recall number
- Z-1474-2023
- Recalling firm
- Stryker Corporation
- Product
- SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
- Status
- Open, Classified
- Initiated
- 2023-03-02
- Posted
- 2023-04-28
- Terminated
- not on file
- Reason
- Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
- Root cause
- Employee error
- Action
- On 3/2/23 recall notices were mailed to customers who were asked to do the following: 1. Inform individuals within your organization who need to be aware of this action. 2. Identify, remove, and quarantine affected devices. 3. If affected product is found, call customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return. 4. Complete and return the Business Reply Form Customers with questions can contact EndoRecall@stryker.com
- Quantity
- 5,228
- Distribution
- Worldwide - US Nationwide distribution including in the states of PA, MS, IL, OH, CA, TX, MO, IN, KS, OK, MT, MA, NE, AZ, NV, NJ, IA, WV, MD, KY, FL, NM, NY, CO, WA, NC, VA, LA, ND, WY, HI SC, UT, OR, SD, AR, TN, AK, CT, GA, ID, VT, NH, MN, WI, DE, RI, AL, MI and the countries of NL, PE, AT, CA, TW, PH, SG, KR, CN.
- Lot, serial or model codes
- Ref/UDI-DI/Lot: 0233-050-100/07613327051650/159190, 159191, 159192, 159194, 159195, 159196, 159197, 159198, 159199, 159200, 159201, 159202, 159203, 159204, 159205, 159206, 159207, 159208, 159209, 159210, 159211, 159212, 159213, 159214, 159215, 159216, 159217, 159218, 164764, 164765, 164766, 164767, 164768, 164769, 164770, 164771, 164772, 164773, 164774, 164775, 164776, 164777, 164778, 164779, 164780, 164781, 164782, 164783, 164784, 164785, 164786, 164787, 164788, 164789, 164790, 164791, 164792, 164793, 164794, 164795, 164796, 164797, 164798, 164799, 164800, 164801, 164802, 164803, 164804, 164805, 164806, 164807, 164808, 164809, 164810, 164811, 164812, 164813, 164814, 164815, 164816, 164817, 164818, 164819, 164820, 164821, 164822, 168940, 168941, 168942, 168943, 168944, 168945, 168946, 168947, 168948, 168949, 168950, 168951, 168952, 168953, 168954, 168955, 168956, 168957, 168958, 168959, 168960, 168961, 168962, 168963, 168964, 168965, 168966, 168967, 168968, 168969, 168970, 168971, 168972, 168973, 168974, 168975, 168976, 168977, 168978, 168979, 168980, 168981, 168987; 0233-050-200/07613327051643/158865, 158868, 158869, 158872, 158874, 158875, 158878, 158884, 165446, 165448, 165451, 165457, 165458, 165459, 165461, 165462, 165464, 168909, 168910, 168911, 168912, 168913, 168914, 168915, 168916, 168917, 168918, 168919, 168920, 168921, 168923, 168924, 168925, 168926, 168927, 168928
- 510(k) numbers
- ["K082813"]
- PMA numbers
- not on file
- Product code
- FCW
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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