Ethicon Endo-Surgery Inc: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

Recall number

Z-0278-2016

Recalling firm

Ethicon Endo-Surgery Inc

Product

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

Status

Terminated

Initiated

2015-09-23

Posted

2015-11-16

Terminated

2016-11-01

Reason

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Root cause

Device Design

Action

On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.

Quantity

441,490 pieces

Distribution

Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.

Lot, serial or model codes

Model # HARH23: Batch # L90K2V, Exp Date 2019-02; Batch # L90K2W, Exp Date 2019-02; Batch # L90K2X, Exp Date 2019-02; Batch # L90V6P, Exp Date 2019-03; Batch #, L9109W, Exp Date, 2019-03; Batch #, L91739, Exp Date, 2019-04; Batch #, L91F3X, Exp Date, 2019-05; Batch #, L91H6F, Exp Date, 2019-05; Batch #, L91M6D, Exp Date, 2019-06; Batch #, L91W4Z, Exp Date, 2019-06; Batch #, L91Z2W, Exp Date, 2019-07; Batch #, L92002, Exp Date, 2019-07; Batch #, L9214D, Exp Date, 2019-07; Batch #, L92194, Exp Date, 2019-07; Batch #, L92673, Exp Date, 2019-08; Batch #, L92E3H, Exp Date, 2019-08; Batch #, L92G7W, Exp Date, 2019-09; Batch #, L92L5R, Exp Date, 2019-09; Batch #, L92L8T, Exp Date, 2019-09; Batch #, L92R3H, Exp Date, 2019-09; Batch #, L92U7M, Exp Date, 2019-10; Batch #, L92W9M, Exp Date, 2019-10; Batch #, L92Y2K, Exp Date, 2019-10; Batch #, L92Y5M, Exp Date, 2019-10; Batch #, L92Z3M, Exp Date, 2019-10; Batch #, L9361Y, Exp Date, 2019-11; Batch #, M9013T, Exp Date, 2019-12; Batch #, M90214, Exp Date, 2019-12; Batch #, M9029F, Exp Date, 2019-12; Batch #, M9041P, Exp Date, 2019-12; Batch #, M90550, Exp Date, 2019-12; Batch #, M90681, Exp Date, 2019-12; Batch #, M9094Y, Exp Date, 2019-12; Batch #, M90H4Y, Exp Date, 2020-01; Batch #, M90K10, Exp Date, 2020-01; Batch #, M90L6V, Exp Date, 2020-02; Batch #, M90N41, Exp Date, 2020-02; Batch #, M90U2V, Exp Date, 2020-02; Batch #, M90X1T, Exp Date, 2020-02; Batch #, M90Y5Y, Exp Date, 2020-02; Batch #, M9107H, Exp Date, 2020-03; Batch #, M9134X, Exp Date, 2020-03; Batch #, M9159T, Exp Date, 2020-03; Batch #, M91788, Exp Date, 2020-03; Batch #, M9180C, Exp Date, 2020-03; Batch #, M91D2P, Exp Date, 2020-04; Batch #, M91D7P, Exp Date, 2020-04; Batch #, M91E14, Exp Date, 2020-04; Batch #, M91J5X, Exp Date, 2020-04; Batch #, M91L28, Exp Date, 2020-05; Batch #, M91M8D, Exp Date, 2020-05; Batch #, M91P44, Exp Date, 2020-05; Batch #, M91P5A, Exp Date, 2020-05; Batch #, M91T75, Exp Date, 2020-05; Batch #, M91W2T, Exp Date, 2020-05; Batch #, M91W5C, Exp Date, 2020-05; Batch #, M91X4J, Exp Date, 2020-05; Batch #, M91X9A, Exp Date, 2020-06; Batch #, M91X9U, Exp Date, 2020-06; Batch #, M92303, Exp Date, 2020-06; Batch #, M9232T, Exp Date, 2020-06; Batch #, M9237E, Exp Date, 2020-06; Batch #, M9243M, Exp Date, 2020-06; Batch #, M9244V, Exp Date, 2020-06; Batch #, M92795, Exp Date, 2020-07; Batch #, M9283L, Exp Date, 2020-07; Batch #, M9294A, Exp Date, 2020-07; Batch #, M92961, Exp Date, 2020-07; Batch #, M92C66, Exp Date, 2020-07; Batch #, M92C90, Exp Date, 2020-07; Batch #, M92E9X, Exp Date, 2020-07; Batch #, M92G56, Exp Date, 2020-07; Batch #, M92G79, Exp Date, 2020-07; Batch #, M92J3C, Exp Date, 2020-08; Batch #, M92L92, Exp Date, 2020-08 & Batch #, M92N00, Exp Date, 2020-08.  Model # HARH36: Batch #, L90K4P, Exp Date, 2019-02; Batch #, L90W33, Exp Date, 2019-03; Batch #, L90W7K, Exp Date, 2019-03; Batch #, L91023, Exp Date, 2019-03; Batch #, L9103T, Exp Date, 2019-03; Batch #, L91080, Exp Date, 2019-03; Batch #, L9110Z, Exp Date, 2019-03; Batch #, L91144, Exp Date, 2019-03; Batch #, L9124Z, Exp Date, 2019-04; Batch #, L9128A, Exp Date, 2019-04; Batch #, L9131N, Exp Date, 2019-04; Batch #, L9138J, Exp Date, 2019-04; Batch #, L9142T, Exp Date, 2019-04; Batch #, L91467, Exp Date, 2019-04; Batch #, L9150V, Exp Date, 2019-04; Batch #, L91562, Exp Date, 2019-04; Batch #, L91884, Exp Date, 2019-04; Batch #, L9191F, Exp Date, 2019-04; Batch #, L91D1W, Exp Date, 2019-05; Batch #, L91D3V, Exp Date, 2019-05; Batch #, L91E0Y, Exp Date, 2019-05; Batch #, L91E5M, Exp Date, 2019-05; Batch #, L91E8N, Exp Date, 2019-05; Batch #, L91H0G, Exp Date, 2019-05; Batch #, L91H9R, Exp Date, 2019-05; Batch #, L91J2N, Exp Date, 2019-05; Batch #, L91K6G, Exp Date, 2019-05; Batch #, L91L6M, Exp Date, 2019-05; Batch #, L91P2Z, Exp Date, 2019-06; Batch #, L91P5D, Exp Date, 2019-06; Batch #, L91P99, Exp Date, 2019-06; Batch #, L91T2H, Exp Date, 2019-06; Batch #, L91T7E, Exp Date, 2019-06; Batch #, L91T9U, Exp Date, 2019-06; Batch #, L91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp Date, 2019-06; Batch #, L91X5P, Exp Date, 2019-07; Batch #, L91Y0X, Exp Date, 2019-07; Batch #, L91Y8W, Exp Date, 2019-07; Batch #, L91Z0N, Exp Date, 2019-07; Batch #, L9204R, Exp Date, 2019-07; Batch #, L92092, Exp Date, 2019-07; Batch #, L9225Y, Exp Date, 2019-07; Batch #, L9232V, Exp Date, 2019-07; Batch #, L9238R, Exp Date, 2019-07; Batch #, L9244H, Exp Date, 2019-07; Batch #, L92524, Exp Date, 2019-07; Batch #, L9255U, Exp Date, 2019-08; Batch #, L9259G, Exp Date, 2019-08; Batch #, L9272N, Exp Date, 2019-08; Batch #, L9284X, Exp Date, 2019-08; Batch #, L9285V, Exp Date, 2019-08; Batch #, L9290A, Exp Date, 2019-08; Batch #, L92921, Exp Date, 2019-08; Batch #, L92952, Exp Date, 2019-08; Batch #, L92987, Exp Date, 2019-08; Batch #, L92A89, Exp Date, 2019-08; Batch #, L92C3L, Exp Date, 2019-08; Batch #, L92C57, Exp Date, 2019-08; Batch #, L92D3K, Exp Date, 2019-08; Batch #, L92D4D, Exp Date, 2019-08; Batch #, L92D9H, Exp Date, 2019-08; Batch #, L92E43, Exp Date, 2019-08; Batch #, L92E8A, Exp Date, 2019-08; Batch #, L92F0U, Exp Date, 2019-08; Batch #, L92F2W, Exp Date, 2019-08; Batch #, L92F5A, Exp Date, 2019-09; Batch #, L92G2F, Exp Date, 2019-09; Batch #, L92G4R, Exp Date, 2019-09; Batch #, L92G9M, Exp Date, 2019-09; Batch #, L92J1A, Exp Date, 2019-09; Batch #, L92J1K, Exp Date, 2019-09; Batch #, L92K1F, Exp Date, 2019-09; Batch #, L92K66, Exp Date, 2019-09; Batch #, L92K9X, Exp Date, 2019-09; Batch #, L92P2A, Exp Date, 2019-09; Batch #, L92P4K, Exp Date, 2019-09; Batch #, L92P5A, Exp Date, 2019-09; Batch #, L92R16, Exp Date, 2019-09; Batch #, L92R2M, Exp Date, 2019-09; Batch #, L92R79, Exp Date, 2019-09; Batch #, L92R95, Exp Date, 2019-09; Batch #, L92T2A, Exp Date, 2019-10; Batch #, L92T64, Exp Date, 2019-10; Batch #, L92T6X, Exp Date, 2019-10; Batch #, L92U09, Exp Date, 2019-10; Batch #, L92U51, Exp Date, 2019-10; Batch #, L92U5K, Exp Date, 2019-10; Batch #, L92V39, Exp Date, 2019-10; Batch #, L92V4E, Exp Date, 2019-10; Batch #, L92V89, Exp Date, 2019-10; Batch #, L92W83, Exp Date, 2019-10; Batch #, L92X1Z, Exp Date, 2019-10; Batch #, L92X5D, Exp Date, 2019-10; Batch #, L92X73, Exp Date, 2019-10; Batch #, L92Y5D, Exp Date, 2019-10; Batch #, L92Y9L, Exp Date, 2019-10; Batch #, L92Z0W, Exp Date, 2019-10; Batch #, L92Z1R, Exp Date, 2019-10; Batch #, L92Z7H, Exp Date, 2019-10; Batch #, L9302N, Exp Date, 2019-10; Batch #, L9307C, Exp Date, 2019-10; Batch #, L93086, Exp Date, 2019-10; Batch #, L9311H, Exp Date, 2019-10; Batch #, L93122, Exp Date, 2019-10; Batch #, L93196, Exp Date, 2019-11; Batch #, L93200, Exp Date, 2019-11; Batch #, L9325A, Exp Date, 2019-11; Batch #, L9327J, Exp Date, 2019-11; Batch #, L93280, Exp Date, 2019-11; Batch #, L9330R, Exp Date, 2019-11; Batch #, L9330W, Exp Date, 2019-11; Batch #, L9333C, Exp Date, 2019-11; Batch #, L9334R, Exp Date, 2019-11; Batch #, L9338D, Exp Date, 2019-11; Batch #, L9339Z, Exp Date, 2019-11; Batch #, L9343C, Exp Date, 2019-11; Batch #, L9347A, Exp Date, 2019-11; Batch #, L9348U, Exp Date, 2019-11; Batch #, L9352A, Exp Date, 2019-11; Batch #, L9353X, Exp Date, 2019-11; Batch #, L9353Y, Exp Date, 2019-11; Batch #, L9356M, Exp Date, 2019-11; Batch #, L9361E, Exp Date, 2019-11; Batch #, L9362R, Exp Date, 2019-11; Batch #, L9362Z, Exp Date, 2019-11; Batch #, L9364G, Exp Date, 2019-11; Batch #, M9002F, Exp Date, 2019-12; Batch #, M9004D, Exp Date, 2019-12; Batch #, M9004N, Exp Date, 2019-12; Batch #, M9016Y, Exp Date, 2019-12; Batch #, M9017T, Exp Date, 2019-12; Batch #, M90235, Exp Date, 2019-12; Batch #, M90275, Exp Date, 2019-12; Batch #, M9027Z, Exp Date, 2019-12; Batch #, M9030P, Exp Date, 2019-12; Batch #, M9038T, Exp Date, 2019-12; Batch #, M90444, Exp Date, 2019-12; Batch #, M9046H, Exp Date, 2019-12; Batch #, M90494, Exp Date, 2019-12; Batch #, M9051C, Exp Date, 2019-12; Batch #, M9057H, Exp Date, 2019-12; Batch #, M90601, Exp Date, 2019-12; Batch #, M9064E, Exp Date, 2019-12; Batch #, M9069Y, Exp Date, 2019-12; Batch #, M9071X, Exp Date, 2019-12; Batch #, M90764, Exp Date, 2019-12; Batch #, M9083G, Exp Date, 2019-12; Batch #, M90880, Exp Date, 2019-12; Batch #, M90902, Exp Date, 2019-12; Batch #, M9091P, Exp Date, 2019-12; Batch #, M9097G, Exp Date, 2019-12; Batch #, M90A5M, Exp Date, 2020-01; Batch #, M90A8A, Exp Date, 2020-01; Batch #, M90C39, Exp Date, 2020-01; Batch #, M90C87, Exp Date, 2020-01; Batch #, M90C88, Exp Date, 2020-01; Batch #, M90C89, Exp Date, 2020-01; Batch #, M90D1E, Exp Date, 2020-01; Batch #, M90D8J, Exp Date, 2020-01; Batch #, M90D9T, Exp Date, 2020-01; Batch #, M90E1U, Exp Date, 2020-01; Batch #, M90F06, Exp Date, 2020-01; Batch #, M90F1W, Exp Date, 2020-01; Batch #, M90F3K, Exp Date, 2020-01; Batch #, M90F5Y, Exp Date, 2020-01; Batch #, M90G00, Exp Date, 2020-01; Batch #, M90G2Y, Exp Date, 2020-01; Batch #, M90G78, Exp Date, 2020-01; Batch #, M90G7Y, Exp Date, 2020-01; Batch #, M90H28, Exp Date, 2020-01; Batch #, M90H7D, Exp Date, 2020-01; Batch #, M90H7E, Exp Date, 2020-01; Batch #, M90H84, Exp Date, 2020-01; Batch #, M90J09, Exp Date, 2020-01; Batch #, M90J6R, Exp Date, 2020-01; Batch #, M90J7R, Exp Date, 2020-01; Batch #, M90K0A, Exp Date, 2020-01; Batch #, M90K5F, Exp Date, 2020-01; Batch #, M90K7A, Exp Date, 2020-01; Batch #, M90K8X, Exp Date, 2020-01; Batch #, M90L1F, Exp Date, 2020-02; Batch #, M90L2K, Exp Date, 2020-02; Batch #, M90L3Z, Exp Date, 2020-02; Batch #, M90L6U, Exp Date, 2020-02; Batch #, M90M34, Exp Date, 2020-02; Batch #, M90M52, Exp Date, 2020-02; Batch #, M90N1M, Exp Date, 2020-02; Batch #, M90N4Z, Exp Date, 2020-02; Batch #, M90N7V, Exp Date, 2020-02  , Batch #, M90P2U, Exp Date, 2020-02; Batch #, M90P5J, Exp Date, 2020-02; Batch #, M90P7K, Exp Date, 2020-02; Batch #, M90R0A, Exp Date, 2020-02; Batch #, M90R2M, Exp Date, 2020-02; Batch #, M90R2N, Exp Date, 2020-02; Batch #, M90R4W, Exp Date, 2020-02; Batch #, M90R7W, Exp Date, 2020-02; Batch #, M90T1J, Exp Date, 2020-02; Batch #, M90T73, Exp Date, 2020-02; Batch #, M90T98, Exp Date, 2020-02; Batch #, M90U35, Exp Date, 2020-02; Batch #, M90U7F, Exp Date, 2020-02; Batch #, M90V0Y, Exp Date, 2020-02; Batch #, M90V32, Exp Date, 2020-02; Batch #, M90V5R, Exp Date, 2020-02; Batch #, M90V91, Exp Date, 2020-02; Batch #, M90W3V, Exp Date, 2020-02; Batch #, M90W6F, Exp Date, 2020-02; Batch #, M90W9J, Exp Date, 2020-02; Batch #, M90X29, Exp Date, 2020-02; Batch #, M90X4P, Exp Date, 2020-02; Batch #, M90X7D, Exp Date, 2020-02; Batch #, M90Y2N, Exp Date, 2020-02; Batch #, M90Y3U, Exp Date, 2020-02; Batch #, M90Y6R, Exp Date, 2020-02; Batch #, M90Y7Z, Exp Date, 2020-03; Batch #, M90Y9P, Exp Date, 2020-03; Batch #, M90Z7K, Exp Date, 2020-03; Batch #, M9100N, Exp Date, 2020-03; Batch #, M9101R, Exp Date, 2020-03; Batch #, M9103R, Exp Date, 2020-03; Batch #, M91110, Exp Date, 2020-03; Batch #, M9111J, Exp Date, 2020-03; Batch #, M9113E, Exp Date, 2020-03; Batch #, M9115C, Exp Date, 2020-03; Batch #, M9117X, Exp Date, 2020-03; Batch #, M91206, Exp Date, 2020-03; Batch #, M9122P, Exp Date, 2020-03; Batch #, M9124V, Exp Date, 2020-03; Batch #, M9127U, Exp Date, 2020-03; Batch #, M9129X, Exp Date, 2020-03; Batch #, M9132N, Exp Date, 2020-03; Batch #, M9134W, Exp Date, 2020-03; Batch #, M91398, Exp Date, 2020-03; Batch #, M9141W, Exp Date, 2020-03; Batch #, M9143P, Exp Date, 2020-03; Batch #, M9145E, Exp Date, 2020-03; Batch #, M9152A, Exp Date, 2020-03; Batch #, M9155F, Exp Date, 2020-03; Batch #, M9155G, Exp Date, 2020-03; Batch #, M9161E, Exp Date, 2020-03; Batch #, M9162M, Exp Date, 2020-03; Batch #, M9168V, Exp Date, 2020-03; Batch #, M91713, Exp Date, 2020-03; Batch #, M9172G, Exp Date, 2020-03; Batch #, M9176J, Exp Date, 2020-03; Batch #, M9180D, Exp Date, 2020-03; Batch #, M9180E, Exp Date, 2020-03; Batch #, M91848, Exp Date, 2020-04; Batch #, M91874, Exp Date, 2020-04; Batch #, M91897, Exp Date, 2020-04; Batch #, M91918, Exp Date, 2020-04; Batch #, M91950, Exp Date, 2020-04; Batch #, M91A06, Exp Date, 2020-04; Batch #, M91A3L, Exp Date, 2020-04; Batch #, M91C5U, Exp Date, 2020-04; Batch #, M91C8D, Exp Date, 2020-04; Batch #, M91D6Y, Exp Date, 2020-04; Batch #, M91D8F, Exp Date, 2020-04; Batch #, M91D8P, Exp Date, 2020-04; Batch #, M91E35, Exp Date, 2020-04; Batch #, M91E71, Exp Date, 2020-04; Batch #, M91E8E, Exp Date, 2020-04; Batch #, M91F2E, Exp Date, 2020-04; Batch #, M91F5D, Exp Date, 2020-04; Batch #, M91F88, Exp Date, 2020-04; Batch #, M91G2U, Exp Date, 2020-04; Batch #, M91G35, Exp Date, 2020-04; Batch #, M91G3Z, Exp Date, 2020-04; Batch #, M91G85, Exp Date, 2020-04; Batch #, M91H3F, Exp Date, 2020-04; Batch #, M91H6F, Exp Date, 2020-04; Batch #, M91H9G, Exp Date, 2020-04; Batch #, M91H9H, Exp Date, 2020-04; Batch #, M91J6A, Exp Date, 2020-04; Batch #, M91J7U, Exp Date, 2020-04; Batch #, M91J9U, Exp Date, 2020-04; Batch #, M91J9Y, Exp Date, 2020-04; Batch #, M91J9Z, Exp Date, 2020-04; Batch #, M91K5T, Exp Date, 2020-05; Batch #, M91L4L, Exp Date, 2020-05; Batch #, M91L4R, Exp Date, 2020-05; Batch #, M91L6V, Exp Date, 2020-05; Batch #, M91M03, Exp Date, 2020-05; Batch #, M91M06, Exp Date, 2020-05; Batch #, M91M1Y, Exp Date, 2020-05; Batch #, M91M29, Exp Date, 2020-05; Batch #, M91M35, Exp Date, 2020-05; Batch #, M91M5Z, Exp Date, 2020-05; Batch #, M91M7M, Exp Date, 2020-05; Batch #, M91N0N, Exp Date, 2020-05; Batch #, M91N15, Exp Date, 2020-05; Batch #, M91N2N, Exp Date, 2020-05; Batch #, M91N2P, Exp Date, 2020-05; Batch #, M91N2T, Exp Date, 2020-05; Batch #, M91N6Z, Exp Date, 2020-05; Batch #, M91N9G, Exp Date, 2020-05; Batch #, M91P2C, Exp Date, 2020-05; Batch #, M91P2D, Exp Date, 2020-05; Batch #, M91P8K, Exp Date, 2020-05; Batch #, M91P91, Exp Date, 2020-05; Batch #, M91R04, Exp Date, 2020-05; Batch #, M91R8A, Exp Date, 2020-05; Batch #, M91R8C, Exp Date, 2020-05; Batch #, M91R94, Exp Date, 2020-05; Batch #, M91T18, Exp Date, 2020-05; Batch #, M91T1N, Exp Date, 2020-05; Batch #, M91T2C, Exp Date, 2020-05; Batch #, M91T2M, Exp Date, 2020-05; Batch #, M91T41, Exp Date, 2020-05; Batch #, M91T7A, Exp Date, 2020-05; Batch #, M91T8F, Exp Date, 2020-05; Batch #, M91U2N, Exp Date, 2020-05; Batch #, M91U46, Exp Date, 2020-05; Batch #, M91U72, Exp Date, 2020-05; Batch #, M91U77, Exp Date, 2020-05; Batch #, M91U80, Exp Date, 2020-05; Batch #, M91U8C, Exp Date, 2020-05; Batch #, M91V2E, Exp Date, 2020-05; Batch #, M91V5J, Exp Date, 2020-05; Batch #, M91V72, Exp Date, 2020-05; Batch #, M91V7W, Exp Date, 2020-05; Batch #, M91V80, Exp Date, 2020-05; Batch #, M91W0E, Exp Date, 2020-05; Batch #, M91W38, Exp Date, 2020-05; Batch #, M91W5F, Exp Date, 2020-05; Batch #, M91W88, Exp Date, 2020-05; Batch #, M91W90, Exp Date, 2020-05; Batch #, M91X06, Exp Date, 2020-05; Batch #, M91X32, Exp Date, 2020-05; Batch #, M91X4F, Exp Date, 2020-05; Batch #, M91X4H, Exp Date, 2020-05; Batch #, M91X4K, Exp Date, 2020-05; Batch #, M91X6K, Exp Date, 2020-05; Batch #, M91X7Y, Exp Date, 2020-06; Batch #, M91Y2G, Exp Date, 2020-06; Batch #, M91Y3C, Exp Date, 2020-06; Batch #, M91Y71, Exp Date, 2020-06; Batch #, M91Y8T, Exp Date, 2020-06; Batch #, M91Z0X, Exp Date, 2020-06; Batch #, M91Z23, Exp Date, 2020-06; Batch #, M91Z39, Exp Date, 2020-06; Batch #, M91Z5E, Exp Date, 2020-06; Batch #, M91Z65, Exp Date, 2020-06; Batch #, M92015, Exp Date, 2020-06; Batch #, M9201W, Exp Date, 2020-06; Batch #, M9204A, Exp Date, 2020-06; Batch #, M9204C, Exp Date, 2020-06; Batch #, M9210M, Exp Date, 2020-06; Batch #, M92120, Exp Date, 2020-06; Batch #, M92141, Exp Date, 2020-06; Batch #, M9214Y, Exp Date, 2020-06; Batch #, M9215L, Exp Date, 2020-06; Batch #, M9217U, Exp Date, 2020-06; Batch #, M9219T, Exp Date, 2020-06; Batch #, M9221P, Exp Date, 2020-06; Batch #, M92233, Exp Date, 2020-06; Batch #, M9226X, Exp Date, 2020-06; Batch #, M9228L, Exp Date, 2020-06; Batch #, M9231D, Exp Date, 2020-06; Batch #, M9232M, Exp Date, 2020-06; Batch #, M92356, Exp Date, 2020-06; Batch #, M9237D, Exp Date, 2020-06; Batch #, M9239T, Exp Date, 2020-06; Batch #, M9240M, Exp Date, 2020-06; Batch #, M9241E, Exp Date, 2020-06; Batch #, M9243X, Exp Date, 2020-06; Batch #, M92443, Exp Date, 2020-06; Batch #, M9246N, Exp Date, 2020-06; Batch #, M9249D, Exp Date, 2020-06; Batch #, M92517, Exp Date, 2020-06; Batch #, M9251J, Exp Date, 2020-06; Batch #, M92554, Exp Date, 2020-06; Batch #, M9255P, Exp Date, 2020-06; Batch #, M9259G, Exp Date, 2020-06; Batch #, M9259T, Exp Date, 2020-06; Batch #, M92613, Exp Date, 2020-06; Batch #, M92634, Exp Date, 2020-06; Batch #, M9264E, Exp Date, 2020-06; Batch #, M9264N, Exp Date, 2020-06; Batch #, M92673, Exp Date, 2020-06; Batch #, M9269M, Exp Date, 2020-07; Batch #, M92718, Exp Date, 2020-07; Batch #, M92738, Exp Date, 2020-07; Batch #, M9275D, Exp Date, 2020-07; Batch #, M9275X, Exp Date, 2020-07; Batch #, M92783, Exp Date, 2020-07; Batch #, M9278N, Exp Date, 2020-07; Batch #, M9280J, Exp Date, 2020-07; Batch #, M92839, Exp Date, 2020-07; Batch #, M9284P, Exp Date, 2020-07; Batch #, M92880, Exp Date, 2020-02; Batch #, M92894, Exp Date, 2020-07; Batch #, M92928, Exp Date, 2020-07; Batch #, M92935, Exp Date, 2020-07; Batch #, M9295Y, Exp Date, 2020-07; Batch #, M9295Z, Exp Date, 2020-07; Batch #, M92A3A, Exp Date, 2020-07; Batch #, M92A59, Exp Date, 2020-07; Batch #, M92A84, Exp Date, 2020-07; Batch #, M92A8U, Exp Date, 2020-07; Batch #, M92C0A, Exp Date, 2020-07; Batch #, M92C2U, Exp Date, 2020-07; Batch #, M92C51, Exp Date, 2020-07; Batch #, M92C76, Exp Date, 2020-07; Batch #, M92C8Z, Exp Date, 2020-07; Batch #, M92C9H, Exp Date, 2020-07; Batch #, M92D1U, Exp Date, 2020-07; Batch #, M92D2G, Exp Date, 2020-07; Batch #, M92D6K, Exp Date, 2020-07; Batch #, M92D6N, Exp Date, 2020-07; Batch #, M92D6P, Exp Date, 2020-07; Batch #, M92D6R, Exp Date, 2020-07; Batch #, M92E1F, Exp Date, 2020-07; Batch #, M92E36, Exp Date, 2020-07; Batch #, M92E4N, Exp Date, 2020-07; Batch #, M92E5X, Exp Date, 2020-07; Batch #, M92E6U, Exp Date, 2020-07; Batch #, M92E7R, Exp Date, 2020-07; Batch #, M92E9V, Exp Date, 2020-07; Batch #, M92F1U, Exp Date, 2020-07; Batch #, M92F1V, Exp Date, 2020-07; Batch #, M92F38, Exp Date, 2020-07; Batch #, M92F3A, Exp Date, 2020-07; Batch #, M92F5J, Exp Date, 2020-07; Batch #, M92F7C, Exp Date, 2020-07; Batch #, M92G0M, Exp Date, 2020-07; Batch #, M92G1P, Exp Date, 2020-07; Batch #, M92G41, Exp Date, 2020-07; Batch #, M92G5F, Exp Date, 2020-07; Batch #, M92G7C, Exp Date, 2020-07; Batch #, M92H07, Exp Date, 2020-07; Batch #, M92H13, Exp Date, 2020-07; Batch #, M92H24, Exp Date, 2020-07; Batch #, M92H3H, Exp Date, 2020-07; Batch #, M92H4M, Exp Date, 2020-07; Batch #, M92H7D, Exp Date, 2020-07; Batch #, M92H9Z, Exp Date, 2020-07; Batch #, M92J2Y, Exp Date, 2020-07; Batch #, M92J9Z, Exp Date, 2020-08; Batch #, M92K27, Exp Date, 2020-08; Batch #, M92K36, Exp Date, 2020-08; Batch #, M92K53, Exp Date, 2020-08; Batch #, M92K71, Exp Date, 2020-08; Batch #, M92K7F, Exp Date, 2020-08; Batch #, M92L14, Exp Date, 2020-08; Batch #, M92L1L, Exp Date, 2020-08; Batch #, M92L1V, Exp Date, 2020-08; Batch #, M92M3V, Exp Date, 2020-08; Batch #, M92M76, Exp Date, 2020-08; Batch #, M92M9G, Exp Date, 2020-08; Batch #, M92N2A, Exp Date, 2020-08; Batch #, M92N4Y, Exp Date, 2020-08 & Batch #, M92N72, Exp Date, 2020-08.  Model # HARH45: Batch #, L90K4R, Exp Date, 2019-02; Batch #, L90V8F, Exp Date, 2019-03; Batch #, L90X10, Exp Date, 2019-03; Batch #, L91358, Exp Date, 2019-04; Batch #, L91600, Exp Date, 2019-04; Batch #, L9166U, Exp Date, 2019-04; Batch #, L9168T, Exp Date, 2019-04; Batch #, L91809, Exp Date, 2019-04; Batch #, L91E83, Exp Date, 2019-05; Batch #, L91G7W, Exp Date, 2019-05; Batch #, L91J6R, Exp Date, 2019-05; Batch #, L91M0D, Exp Date, 2019-06; Batch #, L91M6C, Exp Date, 2019-06; Batch #, L91R4J, Exp Date, 2019-06; Batch #, L91U69, Exp Date, 2019-06; Batch #, L91W66, Exp Date, 2019-06; Batch #, L91Y4Y, Exp Date, 2019-07; Batch #, L91Z72, Exp Date, 2019-07; Batch #, L9207J, Exp Date, 2019-07; Batch #, L92360, Exp Date, 2019-07; Batch #, L9236W, Exp Date, 2019-07; Batch #, L9246M, Exp Date, 2019-07; Batch #, L9252P, Exp Date, 2019-07; Batch #, L9257K, Exp Date, 2019-08; Batch #, L92619, Exp Date, 2019-08; Batch #, L92690, Exp Date, 2019-08; Batch #, L9281C, Exp Date, 2019-08; Batch #, L9288P, Exp Date, 2019-08; Batch #, L9294J, Exp Date, 2019-08; Batch #, L92A2U, Exp Date, 2019-08; Batch #, L92A8A, Exp Date, 2019-08; Batch #, L92C8U, Exp Date, 2019-08; Batch #, L92D7A, Exp Date, 2019-08; Batch #, L92H1J, Exp Date, 2019-09; Batch #, L92H3T, Exp Date, 2019-09; Batch #, L92H79, Exp Date, 2019-09; Batch #, L92H7K, Exp Date, 2019-09; Batch #, L92J40, Exp Date, 2019-09; Batch #, L92K54, Exp Date, 2019-09; Batch #, L92K8Z, Exp Date, 2019-09; Batch #, L92L1C, Exp Date, 2019-09; Batch #, L92M3W, Exp Date, 2019-09; Batch #, L92P9N, Exp Date, 2019-09; Batch #, L92T19, Exp Date, 2019-10; Batch #, L92U1H, Exp Date, 2019-10; Batch #, L92V3L, Exp Date, 2019-10; Batch #, L92V8R, Exp Date, 2019-10; Batch #, L92W46, Exp Date, 2019-10; Batch #, L92X6G, Exp Date, 2019-10; Batch #, L92Y3C, Exp Date, 2019-10; Batch #, L92Y8Z, Exp Date, 2019-10; Batch #, L92Z8P, Exp Date, 2019-10; Batch #, L9303M, Exp Date, 2019-10; Batch #, L93240, Exp Date, 2019-11; Batch #, L93248, Exp Date, 2019-11; Batch #, L93426, Exp Date, 2019-11; Batch #, L9359C, Exp Date, 2019-11; Batch #, M9007E, Exp Date, 2019-12; Batch #, M9007F, Exp Date, 2019-12; Batch #, M90138, Exp Date, 2019-12; Batch #, M9024R, Exp Date, 2019-12; Batch #, M9025P, Exp Date, 2019-12; Batch #, M9030N, Exp Date, 2019-12; Batch #, M9047L, Exp Date, 2019-12; Batch #, M90545, Exp Date, 2019-12; Batch #, M9062G, Exp Date, 2019-12; Batch #, M9080T, Exp Date, 2019-12; Batch #, M90858, Exp Date, 2019-12; Batch #, M9097F, Exp Date, 2019-12; Batch #, M90C11, Exp Date, 2020-01; Batch #, M90C5Y, Exp Date, 2020-01; Batch #, M90D61, Exp Date, 2020-01; Batch #, M90E1V, Exp Date, 2020-01; Batch #, M90F7R, Exp Date, 2020-01; Batch #, M90G3W, Exp Date, 2020-01; Batch #, M90H03, Exp Date, 2020-01; Batch #, M90J4R, Exp Date, 2020-01; Batch #, M90M71, Exp Date, 2020-02; Batch #, M90M9E, Exp Date, 2020-02; Batch #, M90P0E, Exp Date, 2020-02; Batch #, M90T4D, Exp Date, 2020-02; Batch #, M90U8F, Exp Date, 2020-02; Batch #, M90W1V, Exp Date, 2020-02; Batch #, M90X96, Exp Date, 2020-02; Batch #, M90Z1G, Exp Date, 2020-03; Batch #, M90Z52, Exp Date, 2020-03; Batch #, M91053, Exp Date, 2020-03; Batch #, M9125X, Exp Date, 2020-03; Batch #, M9141X, Exp Date, 2020-03; Batch #, M9145F, Exp Date, 2020-03; Batch #, M9164C, Exp Date, 2020-03; Batch #, M9166Y, Exp Date, 2020-03; Batch #, M91984, Exp Date, 2020-04; Batch #, M91D17, Exp Date, 2020-04; Batch #, M91F19, Exp Date, 2020-04; Batch #, M91G1N, Exp Date, 2020-04; Batch #, M91H11, Exp Date, 2020-04; Batch #, M91J0M, Exp Date, 2020-04; Batch #, M91J2G, Exp Date, 2020-04; Batch #, M91L0A, Exp Date, 2020-05; Batch #, M91M1C, Exp Date, 2020-05; Batch #, M91P13, Exp Date, 2020-05; Batch #, M91R3J, Exp Date, 2020-05; Batch #, M91R4M, Exp Date, 2020-05; Batch #, M91R53, Exp Date, 2020-05; Batch #, M91U3L, Exp Date, 2020-05; Batch #, M91V21, Exp Date, 2020-05; Batch #, M91X28, Exp Date, 2020-05; Batch #, M91X4G, Exp Date, 2020-05; Batch #, M91X6W, Exp Date, 2020-06; Batch #, M91Y1Y, Exp Date, 2020-06; Batch #, M91Y3D, Exp Date, 2020-06; Batch #, M91Y7J, Exp Date, 2020-06; Batch #, M9202G, Exp Date, 2020-06; Batch #, M92126, Exp Date, 2020-06; Batch #, M92189, Exp Date, 2020-06; Batch #, M9222C, Exp Date, 2020-06; Batch #, M9224U, Exp Date, 2020-06; Batch #, M9246P, Exp Date, 2020-06; Batch #, M9255N, Exp Date, 2020-06; Batch #, M9273G, Exp Date, 2020-07; Batch #, M92884, Exp Date, 2020-07; Batch #, M9291P, Exp Date, 2020-07; Batch #, M92A24, Exp Date, 2020-07; Batch #, M92A67, Exp Date, 2020-07; Batch #, M92D6L, Exp Date, 2020-07; Batch #, M92E0X, Exp Date, 2020-07; Batch #, M92F1X, Exp Date, 2020-07; Batch #, M92F5K, Exp Date, 2020-07; Batch #, M92F8N, Exp Date, 2020-07; Batch #, M92J31, Exp Date, 2020-08; Batch #, M92J9N, Exp Date, 2020-08; Batch #, M92K6E, Exp Date, 2020-08; Batch #, M92L5C, Exp Date, 2020-08; Batch #, M92L5T, Exp Date, 2020-08; Batch #, M92L7G, Exp Date, 2020-08 & Batch #, M92N47, Exp Date, 2020-08.

510(k) numbers

["K132612"]

PMA numbers

not on file

Product code

LFL

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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