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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Feb 23, 2024 Surgical Instruments Nationwide View Details →

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

Ureteral dilator, REF RBD014

Coloplast Manufacturing US

Class I - Dangerous

A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.

Mar 11, 2024 Other Medical Devices View Details →

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →

BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.

Becton Dickinson &

Class I - Dangerous

Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation.

Feb 29, 2024 Infusion Pumps Nationwide View Details →

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

Exactech

Class I - Dangerous

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Mar 6, 2024 Other Medical Devices Nationwide View Details →